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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
US
AR
AT
21+
BR
CA
CO
HR
CZ
DK
FR
DE
GR
IL
IT
MX
NO
PL
RS
SK
ES
SE
CH
TR
GB

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

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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
Suspended
Not yet recruiting
Terminated
Active, not recruiting
Withdrawn
Recruiting
Any
RESULTS
Instituto de Neurologia de Curitiba - Hospital Ecoville

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

Recruiting
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Clinical Hospital Centar Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

Recruiting
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University Hospital of Patra

Rio 265 04, Greece

Recruiting
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Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Jaczewskiego 8, 20-954 Lublin, Poland

Recruiting
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Clinical Center Nis

Bulevar Dr Zorana Đinđića 48, Niš 18000, Serbia

Recruiting
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Forbes Norris Mda/als Ctr

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

Will be Recruiting
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University Texas Physicians CAR

6410 Fannin St, Houston, TX 77030, USA

Will be Recruiting
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Clinical Hospital Centre Rijeka

Krešimirova ul. 42, 51000, Rijeka, Croatia

Will be Recruiting
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Hospital Britanico de Buenos Aires

Perdriel 74, C1280 AEB, Buenos Aires, Argentina

Recruitment Complete
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Dokuz Eylul University Faculty of Medicine

İnciraltı, Otopark, 35330 Balçova/İzmir, Turkey

Recruitment Complete
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Barrow Neurological Institute

350 W Thomas Rd, Phoenix, AZ 85013, USA

Currently On Hold
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Arizona Neuromuscular Research Center

4545 E Shea Blvd, Phoenix, AZ 85028, USA

Currently On Hold
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University of California-Irvine

Irvine, CA 92697, USA

Currently On Hold
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Regents of the University of colorado

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

Currently On Hold
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Immunoe Research Centers

6801 S Yosemite St, Centennial, CO 80112, USA

Currently On Hold
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University of South Florida

4202 E Fowler Ave, Tampa, FL 33620, USA

Currently On Hold
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University of Kansas Medical Center Research Institute, Inc.

3901 Rainbow Blvd, Kansas City, KS 66160, USA

Currently On Hold
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William Beaumont Hospital

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

Currently On Hold
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Rutgers New Jersey Medical School

185 S Orange Ave, Newark, NJ 07103, USA

Currently On Hold
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Hospital for Special Surgery

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

Currently On Hold
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University of Cincinnati

2600 Clifton Ave, Cincinnati, OH 45221, USA

Currently On Hold
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Cleveland Clinic

9500 Euclid Ave, Cleveland, OH 44195, USA

Currently On Hold
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Austin Neuromuscular Center

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

Currently On Hold
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The Methodist Hospital Research Institute

6670 Bertner Ave, Houston, TX 77030, USA

Currently On Hold
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Hospital Italiano

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

Currently On Hold
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Complejo Medico de la Policia Federal Argentina Churruca Visca

Uspallata 3400, C1437 CABA, Argentina

Currently On Hold
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Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

Montañeses 2325, C1428 AQK, Buenos Aires, Argentina

Currently On Hold
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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
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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
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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
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Hospital Sao Paulo

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

Currently On Hold
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University of Alberta Hospital

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

Currently On Hold
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LHSC - University Hospital

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

Currently On Hold
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Toronto General Hospital

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

Currently On Hold
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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
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Fakultni nemocnice Ostrava

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

Currently On Hold
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Currently On Hold
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CHU de Nice Hôpital Pasteur 2

30 Voie Romaine, 06000 Nice, France

Currently On Hold
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Hôpital de la Timone

278 Rue Saint-Pierre, 13005 Marseille, France

Currently On Hold
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Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Place Amélie Raba Léon, 33076 Bordeaux, France

Currently On Hold
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Hopital Neurologique Pierre Wertheimer

59 Boulevard Pinel, 69500 Bron, France

Currently On Hold
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Universitaetsmedizin Goettingen

Robert-Koch-Straße 40, 37075 Göttingen, Germany

Currently On Hold
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Universitaetsklinikum Essen

Hufelandstraße 55, 45147 Essen, Germany

Currently On Hold
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Universitaetsklinikum Leipzig AoeR

Liebigstraße 18, 04103 Leipzig, Germany

Currently On Hold
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Chaim Sheba Medical Center

Derech Sheba 2, Ramat Gan, Israel

Currently On Hold
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IRCCS Ospedale Casa Sollievo della Sofferenza

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

Currently On Hold
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Istituto Clinico Humanitas

Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy

Currently On Hold
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Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Viale Oxford, 81, 00133 Roma RM, Italy

Currently On Hold
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Azienda Ospedaliero Universitaria San Martino

Largo Rosanna Benzi, 10, 16132 Genova GE, Italy

Currently On Hold
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Azienda Ospedaliera Universitaria Policlinico G. Martino

Via Consolare Valeria, 1, 98124 Messina ME, Italy

Currently On Hold
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Casa di Cura del Policlinico

Via Giuseppe Dezza, 48, 20144 Milano MI, Italy

Currently On Hold
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Fondazione Istituto Neurologico Casimiro Mondino

Via Mondino, 2, 27100 Pavia PV, Italy

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Azienda Ospedaliero Universitaria Pisana

Via Roma, 67, 56126 Pisa PI, Italy

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Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

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

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

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

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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

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Oslo Universitetssykehus HF, Ullevål

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

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COPERNICUS Podmiot Leczniczy Sp. z o. o.,

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

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Uniwersyteckie Centrum Kliniczne

Dębinki 7, 80-952 Gdańsk, Poland

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Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

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

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Clinical Center of Serbia

Pasterova 2, Beograd 11000, Serbia

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Military Medical Academy

Crnotravska 17, Beograd 11000, Serbia

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Fakultna nemocnica Nitra

Špitálska 6, 950 01 Nitra, Slovakia

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Hospital Universitari de Bellvitge

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

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Hospital de la Santa Creu i Sant Pau

Carrer de Sant Quintí, 89, 08041 Barcelona, Spain

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Hospital Universitari Vall d'Hebron

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

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Hospital Universitario Virgen del Rocio

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

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Pamukkale Uni. Med. Fac.

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

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Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

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

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Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

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

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Celal Bayar University Medical Faculty

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

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Southmead Hospital

Southmead Rd, Bristol BS10 5NB, UK

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King's College Hospital

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

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The Walton Centre

Lower Ln, Liverpool L9 7LJ, UK

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Neurology Center of Las Vegas

2480 Professional Ct, Las Vegas, NV 89128, USA

Terminated/Withdrawn
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Århus Universitetshospital

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

Terminated/Withdrawn
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Hallands sjukhus

Lasarettsvägen, 302 33 Halmstad, Sweden

Terminated/Withdrawn
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Kepler Universitätsklinikum

Krankenhausstraße 9, 4020 Linz, Austria

Terminated/Withdrawn
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Vancouver General Hospital

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

Terminated/Withdrawn
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Recherche Sepmus, Inc.

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

Terminated/Withdrawn
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Montreal Neurological Institute Clinical Research Unit

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

Terminated/Withdrawn
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Fundacion Oftalmologica de Santander - FOSCAL

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

Terminated/Withdrawn
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Fundación Valle del Lili

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

Terminated/Withdrawn
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Vseobecna fakultni nemocnice v Praze

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

Terminated/Withdrawn
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Hopital Purpan

9, 9 Place Lange, 31300 Toulouse, France

Terminated/Withdrawn
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Hopital Gui de Chauliac

80 Avenue Augustin Fliche, 38054 Montpellier, France

Terminated/Withdrawn
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CHU Clermont Ferrand - Hopital Gabriel Montpied

58 Rue Montalembert, 63000 Clermont-Ferrand, France

Terminated/Withdrawn
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Bezirksklinikum Regensburg

Universitätsstraße 84, 93053 Regensburg, Germany

Terminated/Withdrawn
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Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

Baldingerstraße, 35043 Marburg, Germany

Terminated/Withdrawn
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Universitaetsmedizin Rostock

Gehlsheimer Str. 20, 18147 Rostock, Germany

Terminated/Withdrawn
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Universitaetsklinikum Duesseldorf AoeR

Universitätsklinikum Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

Terminated/Withdrawn
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Universitaetsklinikum Halle (Saale)

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

Terminated/Withdrawn
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Charité Universitaetsmedizin Berlin - Campus Charité Mitte

Charitépl. 1, 10117 Berlin, Germany

Terminated/Withdrawn
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251 General Air Force Hospital

Leof. Panagioti Kanellopoulou, Athina 115 25, Greece

Terminated/Withdrawn
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Athens Medical Center

Distomou 5-7, Marousi 151 25, Greece

Terminated/Withdrawn
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Tel Aviv Sourasky Medical Center

Weizmann St 6, Tel Aviv-Yafo, Israel

Terminated/Withdrawn
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Hospital Dr. Angel Leaño

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

Terminated/Withdrawn
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Hospital Central Dr Ignacio Morones Prieto

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

Terminated/Withdrawn
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Complejo Hospitalario Universitario de Santiago

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

Terminated/Withdrawn
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Hospital Universitario Ramon y Cajal

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

Terminated/Withdrawn
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

Terminated/Withdrawn
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Hospital Universitari i Politecnic La Fe

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

Terminated/Withdrawn
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Hospital Universitario Miguel Servet

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

Terminated/Withdrawn
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Sahlgrenska universitetssjukhuset

Blå stråket 5, 413 45 Göteborg, Sweden

Terminated/Withdrawn
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Universitaetsspital Zuerich

Rämistrasse 100, 8091 Zürich, Switzerland

Terminated/Withdrawn
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Uludag University Medical Faculty

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

Terminated/Withdrawn
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Bezmialem Vakif

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

Terminated/Withdrawn
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Marmara University Pendik Research and Training Hospital

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

Terminated/Withdrawn
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View all (109)
Trial Protocol ID: 161403
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