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Phase III Efficacy, Safety, and Tolerability Study of HYQVIA/HyQvia and GAMMAGARD LIQUID/KIOVIG in CIDP

IDENTIFIERS
Trial Protocol: 161403
Clinicaltrials.gov: NCT02549170
EudraCT: 2014-005496-87
PURPOSE

This is a Phase III, prospective, multicenter study with two study parts (epochs) to evaluate the efficacy, safety, and tolerability of HYQVIA/HyQvia (IGI, 10% with recombinant human hyaluronidase (rHuPH20) administered subcutaneously) for maintenance therapy to prevent relapse (Epoch 1) and GAMMAGARD LIQUID/KIOVIG (immunoglobulin G intravenous (IGIV) 10% administered intravenously) for the treatment of CIDP (Epoch 2). This study will enroll adult subjects with a confirmed diagnosis of CIDP and who have remained on a stable dosing regimen (monthly equivalent dose of 0.4 to 2.4 g/kg body weight (BW) with a dosing interval of 2 to 6 weeks) of IGIV therapy for at least 3 months prior to screening. In this double-blind, placebo-controlled phase of the study (Epoch 1), eligible subjects will be randomized in a 1:1 ratio to receive either HYQVIA/HyQvia or 0.25% albumin placebo solution with rHuPH20 every two, three, or four weeks in a double-blind fashion for a period of 6 months or until relapse. Subjects who relapse during Epoch 1 will enter Epoch 2 to receive IGIV treatment for a period of 6 months.

Recruiting
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21+
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CA
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Trial at a glance

What medical condition is being studied?   Chronic Inflammatory Demyelinating Polyradiculoneuropathy
What is the trial testing?   HYQVIA; 0.25% albumin placebo solution with rHuPH20; IGIV
How many participants are being enrolled?   232
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
From 18 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

CLICK TO EXPANDCLICK TO COLLAPSE
Trial phase:   Phase 3
Trial Type:   Interventional
Trial Arms/Groups or Cohorts:   
Epoch 1: HYQVIA/HyQvia: Participants will receive SC HYQVIA/HyQvia at a dose of 80 Unit per gram (U/g) immunoglobulin (IgG) which will be same as the participants pre-randomization monthly equivalent IgG dose (or at matching infusion volume for participants in the placebo group) when administered at a dosing frequency of every 2, 3, or 4 weeks for 6 months or until relapse.
Epoch 1: Placebo with rHuPH20: Participants will receive sequential 0.25% albumin placebo with rHuPH20 at a dose of 80U/g IgG subcutaneously for 6 months or until relapse. Dosing regimen for placebo treatment will be the same as the participant's pre-randomization monthly equivalent IgG infusion volume when administered every 2, 3, or 4 weeks.
Epoch 2: IGIV: Participants will recieve an induction dose of 2 Gram per kilogram (g/kg) Intravenous immunoglobulin G (IGIV), followed by maintenance infusions at the same monthly dose as the participant's pre-randomization IgG dose, every 3 weeks for 6 months or until relapse.
Intervention:   HYQVIA; 0.25% albumin placebo solution with rHuPH20; IGIV
Primary Outcome Measure(s):   
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Pre-SC Baseline Week 1 [Time Frame: Pre-SC Baseline (Week 1)]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 5 [Time Frame: Week 5]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 9 [Time Frame: Week 9]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 13 [Time Frame: Week 13]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 15 [Time Frame: Week 15]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 19 [Time Frame: Week 19]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 23 [Time Frame: Week 23]
Epoch 1: Relapse Rate on Every 2 Weeks Dosing Regimen (Q2W) at Week 27 (End of Epoch 1 Treatment [EOE1T])/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Time Frame: Week 27 (EOET1)/UV/ET]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Pre-SC Baseline [Time Frame: Pre-SC Baseline]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 5 [Time Frame: Week 5]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 8 [Time Frame: Week 8]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 11 [Time Frame: Week 11]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 14 [Time Frame: Week 14]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 17 [Time Frame: Week 17]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 20 [Time Frame: Week 20]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 23 [Time Frame: Week 23]
Epoch 1: Relapse Rate on Every 3 Weeks Dosing Regimen (Q3W) at Week 26 (EOE1T)/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Time Frame: Week 26 (EOE1T)/UV/ET]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Pre-SC Baseline [Time Frame: Pre-SC Baseline]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 5 [Time Frame: Week 5]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 8 [Time Frame: Week 8]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 12 [Time Frame: Week 12]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 16 [Time Frame: Week 16]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 20 [Time Frame: Week 20]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 24 [Time Frame: Week 24]
Epoch 1: Relapse Rate on Every 4 Weeks Dosing Regimen (Q4W) at Week 28 (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET) [Time Frame: Week 28 (EOET1)/UV/ET]
Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen at Pre-Baseline (Week 1) [Time Frame: Pre-IV Baseline (Week 1)]
Epoch 2: Responder Rate on Every 3 Weeks Dosing Regimen up to 6 Months (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination [Time Frame: Up to 6 Months/UV/ET]
Secondary Outcome Measure(s):   
Epoch 1: Time to Relapse [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS) Score [Time Frame: Pre-subcutaneous (SC) treatment baseline, then weekly through Epoch 1 (up to 6 months); Unscheduled relapse visit assessment; & if early termination occurs.]
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Participants Experiencing Causally Related Serious And/or Non-Serious Adverse Events (SAEs And/or AEs) [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Participants With Serious And/Or Non-serious Adverse Reactions (ARs) Plus Suspected ARs [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions Associated with Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions Associated with Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs) [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions Temporally Associated with Adverse Events (AEs) [Time Frame: During an infusion or within 72 hours after completion of an infusion]
Epoch 1: Number of Infusions Associated with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions Associated with Treatment-emergent Systemic Adverse Events (AEs) [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions Associated with Treatment-emergent Local Infusion Site Reactions [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Infusions for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs) [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events per Participant-year [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events per Participant-year [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Ars, Expressed as Number of Events per Infusion [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events per Participant-Year [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 1: Number of Participants Who Develop Binding And/Or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20) [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Participants Experiencing Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs) [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Participants with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions Associated with Treatment-emergent Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs), Regardless of Causality [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions Associated With Causally Related Serious And/Or Non-serious Adverse Events (SAEs And/Or AEs) [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions Temporally Associated with Adverse Events (AEs) [Time Frame: During an infusion or within 72 hours after completion of an infusion]
Epoch 2: Number of Infusions Associated with Serious And/Or Non-serious Adverse Reactions (ARs) plus Suspected ARs [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions Associated with Treatment-emergent Systemic Adverse Events (AEs) [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions Associated with Treatment-emergent Local Infusion Site Reactions [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs) [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant-year [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Ars, Expressed as Number of Events Per Infusion [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected ARs, Expressed as Number of Events Per Participant-Year [Time Frame: Throughout Epoch 2, up to 6 months]
Epoch 1: Proportion of Participants Who Experience a Worsening of Functional Disability [Time Frame: Throughout Epoch 1, up to 6 months]
Epoch 2: Proportion of Participants With Clinically Meaningful Improvement in Functional Ability [Time Frame: Throughout Epoch 2, up to 6 months]
Entry Criteria:
Inclusion Criteria: 1. Documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded) consistent with European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria. 2. Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of intravenous immunoglobulin G (IGIV) treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 g/kg BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ± 7 days or monthly dose amount of up to ± 20% between participant’s pre-study IgG infusions are within acceptable limits 3. Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1, or 2 (if at least 1 point is from an upper extremity) must have a history of significant disability - ie, INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. 4. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product. 5. Participant is willing and able to sign an Informed Consent Form (ICF). 6. Participant is willing and able to comply with the requirements of the protocol. Exclusion Criteria: 1. Focal atypical CIDP or pure sensory atypical CIDP. 2. Any neuropathy of other causes, including: a. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), multifocal acquired demyelinating sensory and motor neuropathy (MADSAM), and hereditary sensory and autonomic neuropathies (HSANs) b. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria; systemic lupus erythematosus; polyneuropathy, organomegaly, endocrinopathy or edema, M-protein, skin changes (POEMS) syndrome; osteosclerotic myeloma; diabetic and non-diabetic lumbosacral radiculoplexus neuropathy; lymphoma, and amyloidosis c. Multifocal motor neuropathy (MMN) d. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy 3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein 4. Prominent sphincter disturbance. 5. Central demyelinating disorders (eg, multiple sclerosis). 6. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson’s disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of <7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed.) 7. Congestive heart failure (New York Heart Association (NYHA) Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure >100 mmHg and/or systolic blood pressure >160 mmHg). 8. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months. 9. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome). 10. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m^2 estimated based on CKD-EPI equation (2009). 11. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment. 12. Clinically significant anemia or hemoglobin (Hgb) level of <10.0 g/dL at screening. 13. Hypersensitivity or adverse reactions (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components. 14. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom). 15. Known history of or immunoglobulin A (IgA) deficiency (<8 mg/dL) at screening. 16. Abnormal laboratory values at screening: a. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x upper limit of normal (ULN) b. Platelet count <100,000 cells/µL c. Absolute neutrophil count (ANC) <1000 cells/µL 17. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection. 18. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening. 19. Participant has received or is currently receiving treatment with corticosteroids within 3 months prior to screening. The following exceptions for prednisolone or its equivalent are allowed: stable dosages of low-dose systemic corticosteroids (≤10 mg prednisolone/day or its equivalent) and non-systemic corticosteroids (eg, topical, ophthalmic, or inhaled glucocorticoids). In addition and for the purpose of treating AE or non-CIDP intercurrent disease, a single corticosteroid dose >10 mg prednisolone or a single short term course of ≤ to 7 days (such as Methylprednisolone Dose Pack) within 3 months prior to screening is allowed. 20. Participant has undergone plasma exchange within 3 months prior to screening. 21. The participant has any disorder or condition that in the investigator’s judgment may impede the participant’s participation in the study, pose increased risk to the participant, or confound the results of the study. 22. The participant is nursing or intends to begin nursing during the course of the study. 23. Participation in another clinical study involving an investigational product and/or device within 30 days prior to enrollment, or planned participation in another clinical study during the course of this study. 24. The participant is a family member or employee of the investigator.

Trial Locations

Any
Recruiting
Suspended
Terminated
Withdrawn
Active, not recruiting
Any
RESULTS
Barrow Neurological Institute

350 W Thomas Rd, Phoenix, AZ 85013, USA

Recruiting
2,248 miles (3,618 km)  awayfrom
Massachusetts, United States
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Regents of the University of colorado

13001 E 17th Pl ste f-428, Aurora, CO 80045, USA

Recruiting
1,712 miles (2,755 km)  awayfrom
Massachusetts, United States
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Immunoe Research Centers

6801 S Yosemite St, Centennial, CO 80112, USA

Recruiting
1,718 miles (2,764 km)  awayfrom
Massachusetts, United States
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University of Kansas Medical Center Research Institute, Inc.

3901 Rainbow Blvd, Kansas City, KS 66160, USA

Recruiting
1,204 miles (1,938 km)  awayfrom
Massachusetts, United States
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Rutgers New Jersey Medical School

185 S Orange Ave, Newark, NJ 07103, USA

Recruiting
159 miles (256 km)  awayfrom
Massachusetts, United States
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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

Recruiting
500 miles (804 km)  awayfrom
Massachusetts, United States
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Austin Neuromuscular Center

3901 Medical Pkwy #300, Austin, TX 78756, USA

Recruiting
1,648 miles (2,653 km)  awayfrom
Massachusetts, United States
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University Texas Physicians CAR

6410 Fannin St, Houston, TX 77030, USA

Recruiting
1,565 miles (2,518 km)  awayfrom
Massachusetts, United States
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Instituto de Neurologia de Curitiba - Hospital Ecoville

Rua Jeremias Maciel Perretto, 300 - Campo Comprido, Curitiba - PR, 81210-310, Brazil

Recruiting
4,899 miles (7,884 km)  awayfrom
Massachusetts, United States
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LHSC - University Hospital

339 Windermere Rd, London, ON N6A 5A5, Canada

Recruiting
475 miles (765 km)  awayfrom
Massachusetts, United States
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Clinical Hospital Centre Rijeka

Krešimirova ul. 42, 51000, Rijeka, Croatia

Recruiting
4,092 miles (6,586 km)  awayfrom
Massachusetts, United States
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Clinical Hospital Centar Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

Recruiting
4,140 miles (6,663 km)  awayfrom
Massachusetts, United States
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CHU de Nice Hôpital Pasteur 2

30 Voie Romaine, 06000 Nice, France

Recruiting
3,841 miles (6,181 km)  awayfrom
Massachusetts, United States
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Hôpital de la Timone

278 Rue Saint-Pierre, 13005 Marseille, France

Recruiting
3,772 miles (6,070 km)  awayfrom
Massachusetts, United States
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Universitaetsmedizin Goettingen

Robert-Koch-Straße 40, 37075 Göttingen, Germany

Recruiting
3,710 miles (5,971 km)  awayfrom
Massachusetts, United States
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Universitaetsklinikum Leipzig AoeR

Liebigstraße 18, 04103 Leipzig, Germany

Recruiting
3,812 miles (6,134 km)  awayfrom
Massachusetts, United States
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University Hospital of Patra

Rio 265 04, Greece

Recruiting
4,678 miles (7,529 km)  awayfrom
Massachusetts, United States
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Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

Vasco de Quiroga 15, Belisario Domínguez Secc 16, Tlalpan, 14080 Ciudad de México, CDMX, Mexico

Recruiting
2,247 miles (3,617 km)  awayfrom
Massachusetts, United States
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Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Jaczewskiego 8, 20-954 Lublin, Poland

Recruiting
4,197 miles (6,755 km)  awayfrom
Massachusetts, United States
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Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

Dr. Stefana Kopcińskiego 22, 90-001 Łódź, Poland

Recruiting
4,066 miles (6,543 km)  awayfrom
Massachusetts, United States
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Clinical Center Nis

Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia

Recruiting
4,478 miles (7,207 km)  awayfrom
Massachusetts, United States
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Hospital Universitari de Bellvitge

Carrer de la Feixa Llarga, s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Spain

Recruiting
3,685 miles (5,930 km)  awayfrom
Massachusetts, United States
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Hospital Universitari Vall d'Hebron

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

Recruiting
3,684 miles (5,929 km)  awayfrom
Massachusetts, United States
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Dokuz Eylul University Faculty of Medicine

İnciraltı, Otopark, 35330 Balçova/İzmir, Turkey

Recruitment Complete
4,897 miles (7,881 km)  awayfrom
Massachusetts, United States
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Arizona Neuromuscular Research Center

4545 E Shea Blvd, Phoenix, AZ 85028, USA

Currently On Hold
2,240 miles (3,605 km)  awayfrom
Massachusetts, United States
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HonorHealth Neurology

3501 N Scottsdale Rd Ste. 280A, Scottsdale, AZ 85251, USA

Currently On Hold
2,240 miles (3,605 km)  awayfrom
Massachusetts, United States
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University of California-Irvine

Irvine, CA 92697, USA

Currently On Hold
2,538 miles (4,084 km)  awayfrom
Massachusetts, United States
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Forbes Norris Mda/als Ctr

1100 Van Ness Ave 6th Floor, San Francisco, CA 94109, USA

Currently On Hold
2,648 miles (4,261 km)  awayfrom
Massachusetts, United States
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University of South Florida

4202 E Fowler Ave, Tampa, FL 33620, USA

Currently On Hold
1,147 miles (1,845 km)  awayfrom
Massachusetts, United States
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William Beaumont Hospital

3601 W 13 Mile Rd, Royal Oak, MI 48073, USA

Currently On Hold
573 miles (922 km)  awayfrom
Massachusetts, United States
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Hospital for Special Surgery

Hospital for Special Surgery, 535 E 70th St, New York, NY 10021, USA

Currently On Hold
149 miles (240 km)  awayfrom
Massachusetts, United States
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Wake Forest University

1834 Wake Forest Rd, Winston-Salem, NC 27109, USA

Currently On Hold
617 miles (992 km)  awayfrom
Massachusetts, United States
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University of Cincinnati

2600 Clifton Ave, Cincinnati, OH 45221, USA

Currently On Hold
692 miles (1,114 km)  awayfrom
Massachusetts, United States
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Hospital Italiano

Pres. Tte. Gral. Juan Domingo Perón 4190, C1199 ABH, Buenos Aires, Argentina

Currently On Hold
5,383 miles (8,664 km)  awayfrom
Massachusetts, United States
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Hospital Britanico de Buenos Aires

Perdriel 74, C1280 AEB, Buenos Aires, Argentina

Currently On Hold
5,386 miles (8,667 km)  awayfrom
Massachusetts, United States
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Complejo Medico de la Policia Federal Argentina Churruca Visca

Uspallata 3400, C1437 CABA, Argentina

Currently On Hold
5,386 miles (8,668 km)  awayfrom
Massachusetts, United States
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Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

Montañeses 2325, C1428 AQK, Buenos Aires, Argentina

Currently On Hold
5,380 miles (8,658 km)  awayfrom
Massachusetts, United States
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HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense

R. Marquês de Paraná, 303 - Centro, Niterói - RJ, 24033-900, Brazil

Currently On Hold
4,867 miles (7,833 km)  awayfrom
Massachusetts, United States
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Hospital das Clínicas da Faculdade de Medicina da UNICAMP

R. Vital Brasil, 251 - Cidade Universitária, Campinas - SP, 13083-888, Brazil

Currently On Hold
4,773 miles (7,682 km)  awayfrom
Massachusetts, United States
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Hospital das Clínicas FMRP-USP

R. Ten. Catão Roxo, 3900 - Vila Monte Alegre, Ribeirão Preto - SP, 14015-010, Brazil

Currently On Hold
4,648 miles (7,480 km)  awayfrom
Massachusetts, United States
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Hospital Sao Paulo

Hospital São Paulo - Vila Clementino, São Paulo - SP, 04039-000, Brazil

Currently On Hold
4,832 miles (7,777 km)  awayfrom
Massachusetts, United States
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University of Alberta Hospital

8440 112 St NW, Edmonton, AB T6G 2B7, Canada

Currently On Hold
2,039 miles (3,281 km)  awayfrom
Massachusetts, United States
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Toronto General Hospital

200 Elizabeth St, Toronto, ON M5G 2C4, Canada

Currently On Hold
386 miles (622 km)  awayfrom
Massachusetts, United States
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Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

Cl. 69 ##51c-24, Medellín, Antioquia, Colombia

Currently On Hold
2,501 miles (4,025 km)  awayfrom
Massachusetts, United States
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University Hospital Centre "Sestre Milosrdnice"

Vinogradska cesta 29, 10000, Zagreb, Croatia

Currently On Hold
4,138 miles (6,660 km)  awayfrom
Massachusetts, United States
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Fakultni nemocnice Brno

Jihlavská 340/20, 625 00 Brno-Bohunice-Brno-Starý Lískovec, Czechia

Currently On Hold
4,045 miles (6,509 km)  awayfrom
Massachusetts, United States
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Fakultni nemocnice Ostrava

17. listopadu 1790, 708 00 Ostrava-Poruba, Czechia

Currently On Hold
4,084 miles (6,572 km)  awayfrom
Massachusetts, United States
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Currently On Hold
3,927 miles (6,320 km)  awayfrom
Massachusetts, United States
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Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Place Amélie Raba Léon, 33076 Bordeaux, France

Currently On Hold
3,457 miles (5,564 km)  awayfrom
Massachusetts, United States
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Hopital Neurologique Pierre Wertheimer

59 Boulevard Pinel, 69500 Bron, France

Currently On Hold
3,673 miles (5,911 km)  awayfrom
Massachusetts, United States
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Universitaetsklinikum Essen

Hufelandstraße 55, 45147 Essen, Germany

Currently On Hold
3,597 miles (5,789 km)  awayfrom
Massachusetts, United States
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Chaim Sheba Medical Center

Derech Sheba 2, Ramat Gan, Israel

Currently On Hold
5,517 miles (8,879 km)  awayfrom
Massachusetts, United States
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IRCCS Ospedale Casa Sollievo della Sofferenza

Viale Cappuccini, 1, 71013 San Giovanni Rotondo FG, Italy

Currently On Hold
4,279 miles (6,887 km)  awayfrom
Massachusetts, United States
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Istituto Clinico Humanitas

Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy

Currently On Hold
3,869 miles (6,226 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Viale Oxford, 81, 00133 Roma RM, Italy

Currently On Hold
4,140 miles (6,663 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliero Universitaria San Martino

Largo Rosanna Benzi, 10, 16132 Genova GE, Italy

Currently On Hold
3,892 miles (6,263 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliera Universitaria Policlinico G. Martino

Via Consolare Valeria, 1, 98124 Messina ME, Italy

Currently On Hold
4,408 miles (7,095 km)  awayfrom
Massachusetts, United States
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Casa di Cura del Policlinico

Via Giuseppe Dezza, 48, 20144 Milano MI, Italy

Currently On Hold
3,866 miles (6,221 km)  awayfrom
Massachusetts, United States
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Fondazione Istituto Neurologico Casimiro Mondino

Via Mondino, 2, 27100 Pavia PV, Italy

Currently On Hold
3,873 miles (6,233 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliero Universitaria Pisana

Via Roma, 67, 56126 Pisa PI, Italy

Currently On Hold
3,977 miles (6,400 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

Piazzale Aldo Moro, 3/5, 00185 Roma RM, Italy

Currently On Hold
4,133 miles (6,652 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

Currently On Hold
3,815 miles (6,140 km)  awayfrom
Massachusetts, United States
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Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Piazzale Santa Maria della Misericordia, 15, 33100 Udine UD, Italy

Currently On Hold
4,016 miles (6,463 km)  awayfrom
Massachusetts, United States
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Oslo Universitetssykehus HF, Ullevål

Bygg 19, Gaustad Sykehus, Sognsvannsveien 21, 0188 Oslo, Norway

Currently On Hold
3,520 miles (5,666 km)  awayfrom
Massachusetts, United States
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COPERNICUS Podmiot Leczniczy Sp. z o. o.,

Nowe Ogrody 1-6, 80-803 Gdańsk, Poland

Currently On Hold
3,948 miles (6,353 km)  awayfrom
Massachusetts, United States
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Uniwersyteckie Centrum Kliniczne

Dębinki 7, 80-952 Gdańsk, Poland

Currently On Hold
3,947 miles (6,352 km)  awayfrom
Massachusetts, United States
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Clinical Center of Serbia

Pasterova 2, Beograd 11000, Serbia

Currently On Hold
4,360 miles (7,017 km)  awayfrom
Massachusetts, United States
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Military Medical Academy

Crnotravska 17, Beograd 11000, Serbia

Currently On Hold
4,362 miles (7,020 km)  awayfrom
Massachusetts, United States
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Fakultna nemocnica Nitra

Špitálska 6, 950 01 Nitra, Slovakia

Currently On Hold
4,135 miles (6,654 km)  awayfrom
Massachusetts, United States
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Hospital de la Santa Creu i Sant Pau

Carrer de Sant Quintí, 89, 08041 Barcelona, Spain

Currently On Hold
3,686 miles (5,932 km)  awayfrom
Massachusetts, United States
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Hospital Universitario Virgen del Rocio

Av. Manuel Siurot, S/n, 41013 Sevilla, Spain

Currently On Hold
3,429 miles (5,518 km)  awayfrom
Massachusetts, United States
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Pamukkale Uni. Med. Fac.

Çamlaraltı, Pamukkale Ünv. Hastane Yolu, 20070 Kınıklı/Pamukkale/Denizli, Turkey

Currently On Hold
5,013 miles (8,067 km)  awayfrom
Massachusetts, United States
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Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Cerrahpaşa, Koca Mustafapaşa Cd. No:53 D:No:53, 34096 Fatih/İstanbul, Turkey

Currently On Hold
4,861 miles (7,822 km)  awayfrom
Massachusetts, United States
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Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

Ardıçlı, Akademi, Celal Bayar Cd. No:313, 42250 Selçuklu/Konya, Turkey

Currently On Hold
5,139 miles (8,271 km)  awayfrom
Massachusetts, United States
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Celal Bayar University Medical Faculty

Şehit Prof. Dr. İlhan Varank Kampüsü, Yağcılar, 45140 Yunusemre/Manisa, Turkey

Currently On Hold
4,896 miles (7,879 km)  awayfrom
Massachusetts, United States
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Southmead Hospital

Southmead Rd, Bristol BS10 5NB, UK

Currently On Hold
3,209 miles (5,164 km)  awayfrom
Massachusetts, United States
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King's College Hospital

Denmark Hill, Herne Hill, London SE5 9RS, UK

Currently On Hold
3,312 miles (5,329 km)  awayfrom
Massachusetts, United States
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The Walton Centre

Lower Ln, Liverpool L9 7LJ, UK

Currently On Hold
3,157 miles (5,081 km)  awayfrom
Massachusetts, United States
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Neurology Center of Las Vegas

2480 Professional Ct, Las Vegas, NV 89128, USA

2,328 miles (3,747 km)  awayfrom
Massachusetts, United States
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The Methodist Hospital Research Institute

6670 Bertner Ave, Houston, TX 77030, USA

1,565 miles (2,518 km)  awayfrom
Massachusetts, United States
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Århus Universitetshospital

P. P. Ørums Gade 11, 8000 Aarhus, Denmark

3,594 miles (5,784 km)  awayfrom
Massachusetts, United States
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Hallands sjukhus

Lasarettsvägen, 302 33 Halmstad, Sweden

3,674 miles (5,913 km)  awayfrom
Massachusetts, United States
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Kepler Universitätsklinikum

Krankenhausstraße 9, 4020 Linz, Austria

3,985 miles (6,413 km)  awayfrom
Massachusetts, United States
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Vancouver General Hospital

899 W 12th Ave, Vancouver, BC V5Z 1M9, Canada

2,462 miles (3,962 km)  awayfrom
Massachusetts, United States
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Recherche Sepmus, Inc.

4896 Boulevard Taschereau suite 250, Greenfield Park, QC J4V 2J2, Canada

231 miles (372 km)  awayfrom
Massachusetts, United States
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Montreal Neurological Institute Clinical Research Unit

3801 Rue University, Montréal, QC H3A 2B4, Canada

235 miles (378 km)  awayfrom
Massachusetts, United States
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Fundacion Oftalmologica de Santander - FOSCAL

Cl. 157 #23-99, Floridablanca, Santander, Colombia

2,436 miles (3,921 km)  awayfrom
Massachusetts, United States
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Fundación Valle del Lili

Cra. 98 ## 18-49, Cali, Valle del Cauca, Colombia

2,706 miles (4,354 km)  awayfrom
Massachusetts, United States
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Vseobecna fakultni nemocnice v Praze

U Nemocnice 499/2, 128 08 Praha 2-Nové Město, Czechia

3,930 miles (6,325 km)  awayfrom
Massachusetts, United States
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Hopital Purpan

9, 9 Place Lange, 31300 Toulouse, France

3,584 miles (5,769 km)  awayfrom
Massachusetts, United States
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Hopital Gui de Chauliac

80 Avenue Augustin Fliche, 38054 Montpellier, France

3,692 miles (5,942 km)  awayfrom
Massachusetts, United States
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CHU Clermont Ferrand - Hopital Gabriel Montpied

58 Rue Montalembert, 63000 Clermont-Ferrand, France

3,594 miles (5,784 km)  awayfrom
Massachusetts, United States
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Bezirksklinikum Regensburg

Universitätsstraße 84, 93053 Regensburg, Germany

3,873 miles (6,233 km)  awayfrom
Massachusetts, United States
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Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

Baldingerstraße, 35043 Marburg, Germany

3,686 miles (5,933 km)  awayfrom
Massachusetts, United States
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Universitaetsmedizin Rostock

Gehlsheimer Str. 20, 18147 Rostock, Germany

3,720 miles (5,987 km)  awayfrom
Massachusetts, United States
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Universitaetsklinikum Duesseldorf AoeR

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

3,596 miles (5,787 km)  awayfrom
Massachusetts, United States
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Universitaetsklinikum Halle (Saale)

Ernst-Grube-Straße 40, 06120 Halle (Saale), Germany

3,789 miles (6,098 km)  awayfrom
Massachusetts, United States
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Charité Universitaetsmedizin Berlin - Campus Charité Mitte

Charitépl. 1, 10117 Berlin, Germany

3,813 miles (6,136 km)  awayfrom
Massachusetts, United States
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251 General Air Force Hospital

Leof. Panagioti Kanellopoulou, Athina 115 25, Greece

4,777 miles (7,687 km)  awayfrom
Massachusetts, United States
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Athens Medical Center

Distomou 5-7, Marousi 151 25, Greece

4,776 miles (7,685 km)  awayfrom
Massachusetts, United States
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Tel Aviv Sourasky Medical Center

Weizmann St 6, Tel Aviv-Yafo, Israel

5,514 miles (8,873 km)  awayfrom
Massachusetts, United States
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Hospital Dr. Angel Leaño

Av. Dr. Angel Leaño 500, Los Robles, 45200 Nuevo México, Jal., Mexico

2,353 miles (3,787 km)  awayfrom
Massachusetts, United States
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Hospital Central Dr Ignacio Morones Prieto

Av Venustiano Carranza S/N, Zona Universitaria, 78290 San Luis, S.L.P., Mexico

2,178 miles (3,504 km)  awayfrom
Massachusetts, United States
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Complejo Hospitalario Universitario de Santiago

Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain

3,145 miles (5,061 km)  awayfrom
Massachusetts, United States
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Hospital Universitario Ramon y Cajal

M-607, km. 9, 100, 28034 Madrid, Spain

3,441 miles (5,538 km)  awayfrom
Massachusetts, United States
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

3,442 miles (5,539 km)  awayfrom
Massachusetts, United States
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Hospital Universitari i Politecnic La Fe

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

3,630 miles (5,843 km)  awayfrom
Massachusetts, United States
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Hospital Universitario Miguel Servet

Paseo Isabel la Católica, 1-3, 50009 Zaragoza, Spain

3,537 miles (5,692 km)  awayfrom
Massachusetts, United States
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Sahlgrenska universitetssjukhuset

Blå stråket 5, 413 45 Göteborg, Sweden

3,617 miles (5,821 km)  awayfrom
Massachusetts, United States
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Universitaetsspital Zuerich

Rämistrasse 100, 8091 Zürich, Switzerland

3,779 miles (6,081 km)  awayfrom
Massachusetts, United States
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Uludag University Medical Faculty

Özlüce Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

4,892 miles (7,874 km)  awayfrom
Massachusetts, United States
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Bezmialem Vakif

Adnan Menderes Bulvarı, Topkapı, Vatan Caddesi, 34093 Fatih/İstanbul, Turkey

4,860 miles (7,821 km)  awayfrom
Massachusetts, United States
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Marmara University Pendik Research and Training Hospital

Fevzi Çakmak, Muhsin Yazıcıoğlu Cd No:10, 34899 Pendik/İstanbul, Turkey

4,879 miles (7,852 km)  awayfrom
Massachusetts, United States
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View all (113)
Trial Protocol ID: 161403
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