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Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Recombinant FVIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years of Age With Severe Hemophilia A

IDENTIFIERS
Trial Protocol: 261203
Clinicaltrials.gov: NCT02615691
EudraCT: 2015-002136-40
PURPOSE

The purpose of this study is to investigate safety, immunogenicity and hemostatic efficacy of PEGylated recombinant FVIII (BAX 855) in previously untreated patients (PUPs) < 6 years of age with severe hemophilia A (baseline FVIII level < 1%) and < 3 EDs to ADVATE, BAX 855 or plasma transfusion.

Recruiting
US
AT
BE
21+
BG
CA
CZ
DK
FI
FR
DE
HK
HU
IT
KR
MY
NL
NO
SG
ES
TW
TH
TR
UA
GB

Trial at a glance

What medical condition is being studied?   Hemophilia A
What is the trial testing?   PEGylated Recombinant Factor VIII
How many participants are being enrolled?   120
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
Up to 5 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:   
Previously untreated patients (PUPs): <6 years of age with severe hemophilia A (baseline Factor VIII (FVIII) level < 1%)
Intervention:   PEGylated Recombinant Factor VIII
Primary Outcome Measure(s):   
Incidence of FVIII inhibitor development [Time Frame: Throughout Part A of the study, approximately 5 years]
Success rate of Immune tolerance induction (ITI) [Time Frame: Up to 33 months]
Secondary Outcome Measure(s):   
Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies [Time Frame: Throughout Part A of the study, approximately 5 years]
Clinically significant adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Throughout Part A and Part B of the study, approximately 7 years]
Clinically significant changes in vital signs [Time Frame: Throughout Part A and Part B of the study, approximately 7 years]
Clinically significant changes in clinical laboratory parameters [Time Frame: Throughout Part A and Part B of the study, approximately 7 years]
Annualized bleeding rate (ABR) for prophylactic and on-demand treatment [Time Frame: Throughout Part A of the study, approximately 5 years]
Number of BAX 855 infusions per bleeding episode [Time Frame: Throughout Part A of the study, approximately 5 years]
Overall hemostatic efficacy rating [Time Frame: 24 h after initiation of treatment and at resolution of bleed]
Weight-adjusted consumption of BAX 855 per month, per year and per event [Time Frame: Throughout Part A of the study, approximately 5 years]
Number of infusions per month and per year [Time Frame: Throughout Part A of the study, approximately 5 years]
Assessment of intra-, post- and perioperative hemostatic efficacy in case of surgery [Time Frame: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)]
Intra- and postoperative blood loss in case of surgery [Time Frame: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)]
Pharmacokinetics- Incremental recovery (IR) at baseline and over time [Time Frame: Pre-infusion within 30 minutes; and post-infusion at 15-30 minutes and 24-48 hours]
Pharmacokinetics- Half-life (T1/2) at baseline (optional) [Time Frame: Post-infusion: 15-30 minutes and 24-48 hours]
Immune tolerance induction (ITI) - Rate of partial success and failure of ITI [Time Frame: Up to 33 months]
Immune tolerance induction (ITI) - annualized bleeding rate (ABR) during ITI [Time Frame: Up to 33 months]
Immune tolerance induction (ITI) - Weight-adjusted consumption of BAX 855 per month and per year for each ITI regimen employed [Time Frame: Up to 33 months]
Immune tolerance induction (ITI) - Catheter-related complications [Time Frame: Up to 33 months]
Immune tolerance induction (ITI) -Binding Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies [Time Frame: Up to 33 months]
Entry Criteria:
Inclusion Criteria 1. Participant is < 6 years old at the time of screening 2. Participant is previously untreated with < 3 exposure days (EDs) to ADVATE, BAX 855 or plasma transfusion at any time prior to screening 3. Participant has severe hemophilia A (Factor VIII (FVIII) < 1%) as determined by the central laboratory, or a historical FVIII level < 1% as determined at any local laboratory, optionally supported by an additional FVIII gene mutation consistent with severe hemophilia A 4. Participant is immune competent with a CD4+ count > 200 cells/mm^3, as confirmed by the central laboratory at screening 5. Parent or legally authorized representative is willing and able to comply with the requirements of the protocol Additional inclusion criteria for Part B (immune tolerance induction (ITI)) 1. Parent or legal representative has/have voluntarily provided signed informed consent for ITI portion 2. Participant has a confirmed positive high titer inhibitor (> 5.00 Bethesda unit (BU)) or has a positive confirmed low titer inhibitor (≥ 0.6 BU) as determined by the central laboratory based on a second repeat blood sample with a. poorly controlled bleeding despite increased BAX 855 doses, or b. requires bypassing agents to treat bleeding Exclusion Criteria 1. Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening 2. Participant has a history of FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay or the Bethesda assay) at any time prior to screening 3. Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand’s disease) 4. Participant has been previously treated with any type of FVIII concentrate other than ADVATE or BAX 855, or was administered ADVATE, BAX 855 or plasma transfusion for ≥ 3 EDs at any time prior to screening 5. Participant receives >2 EDs of ADVATE in total during the periods prior to enrollment and during the screening period, until the baseline infusion. 6. The participant’s weight is anticipated to be < 5 kg at the baseline visit 7. Participant’s platelet count is < 100,000/mL 8. Participant has known hypersensitivity towards mouse or hamster proteins, polyethylene glycol (PEG) or Tween 80 9. Participant has severe chronic hepatic dysfunction [eg, > 5 times upper limit of normal alanine aminotransferase (ALT), aspartate aminotransferase (AST), or a documented international normalized ratio (INR) > 1.5] in his medical history or at the time of screening 10. Participant has severe renal impairment (serum creatinine > 1.5 times the upper limit of normal) 11. Participant has current or recent (< 30 days) use of other PEGylated drugs prior to study participation or is scheduled to use such drugs during study participation 12. Participant is scheduled to receive during the course of the study a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day or α-interferon) other than anti-retroviral chemotherapy 13. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study 14. Parent or legally authorized representative has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance 15. Parent, legally authorized representative or participant are a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study. Additional exclusion criteria for Part B (ITI) 1. Spontaneous disappearance of the inhibitor prior to ITI 2. FVIII inhibitor titer ≥ 0.6 BU is not confirmed by a second new blood sample and determined at the central laboratory 3. Inability or unwillingness to comply with the protocol

Trial Locations

Any
Recruiting
Suspended
Withdrawn
Any
RESULTS
Phoenix Childrens Hospital

1919 E Thomas Rd, Phoenix, AZ 85016, USA

Recruiting
2,139 miles (3,442 km)  awayfrom
New York City, New York
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Kaiser Permanente Oakland M.C.

10050 N Wolfe Rd, Cupertino, CA 95014, USA

Site Contact
Recruiting
2,556 miles (4,114 km)  awayfrom
New York City, New York
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Kaiser Permanente Oakland M.C.

3600 Broadway, Oakland, CA 94611, USA

Site Contact
Recruiting
2,557 miles (4,115 km)  awayfrom
New York City, New York
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Kaiser Permanente Oakland M.C.

1600 Eureka Rd, Roseville, CA 95661, USA

Site Contact
Recruiting
2,484 miles (3,998 km)  awayfrom
New York City, New York
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UC Davis Health System

2315 Stockton Blvd, Sacramento, CA 95817, USA

Recruiting
2,499 miles (4,021 km)  awayfrom
New York City, New York
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Connecticut Children's Med Ctr

282 Washington St, Hartford, CT 06106, USA

Site Contact
Recruiting
96 miles (155 km)  awayfrom
New York City, New York
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Univ Florida College Medicine

2015 SW 16th Ave, Gainesville, FL 32608, USA

Recruiting
902 miles (1,451 km)  awayfrom
New York City, New York
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Center for Advanced Pediatrics

1400 Tullie Rd NE, Atlanta, GA 30329, USA

Recruiting
743 miles (1,195 km)  awayfrom
New York City, New York
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Ann & Robert H. Lurie Children's H

225 E Chicago Ave, Chicago, IL 60611, USA

Recruiting
711 miles (1,145 km)  awayfrom
New York City, New York
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Bleeding and Clotting Dis.Inst.

9128 N Lindbergh Dr, Peoria, IL 61615, USA

Recruiting
817 miles (1,314 km)  awayfrom
New York City, New York
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UMHS

2903 Baxter Rd, Ann Arbor, MI 48109, USA

Recruiting
514 miles (827 km)  awayfrom
New York City, New York
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New York Presbyterian Hospital

525 E 68th St, New York, NY 10065, USA

Recruiting
1.39 miles (2.24 km)  awayfrom
New York City, New York
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Novant Health Presbyterian Medical Center

200 Hawthorne Ln, Charlotte, NC 28204, USA

Recruiting
534 miles (860 km)  awayfrom
New York City, New York
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Wake Forest Baptist Medical Center

1 Medical Center Blvd, Winston-Salem, NC 27157, USA

Recruiting
469 miles (755 km)  awayfrom
New York City, New York
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Cincinnati Children's Hospital

3333 Burnet Ave, Cincinnati, OH 45229, USA

Recruiting
568 miles (914 km)  awayfrom
New York City, New York
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Rainbow Babies/Childrens Htl

11100 Euclid Ave, Cleveland, OH 44106, USA

Recruiting
400 miles (644 km)  awayfrom
New York City, New York
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Penn State MS Hershey Med Ctr

500 University Dr, Hershey, PA 17033, USA

Recruiting
146 miles (234 km)  awayfrom
New York City, New York
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Texas Tech University Health Sciences Center

4801 Alberta Ave 3rd fl, El Paso, TX 79905, USA

Recruiting
1,899 miles (3,056 km)  awayfrom
New York City, New York
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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

Recruiting
1,424 miles (2,292 km)  awayfrom
New York City, New York
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Primary Children's Hospital

100 Mario Capecchi Dr, Salt Lake City, UT 84113, USA

Recruiting
1,965 miles (3,163 km)  awayfrom
New York City, New York
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HUDERF

Avenue Jean Joseph Crocq 15, 1020 Bruxelles, Belgium

Recruiting
3,654 miles (5,880 km)  awayfrom
New York City, New York
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Cliniques Uni Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

Recruiting
3,660 miles (5,889 km)  awayfrom
New York City, New York
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Univ. Ziekenhuis Gent Apotheek

Zwijnaardsesteenweg 566, 9000 Gent, Belgium

Recruiting
3,626 miles (5,835 km)  awayfrom
New York City, New York
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Universitair Ziekenhuis Leuven

Herestraat 49, 3000 Leuven, Belgium

Recruiting
3,668 miles (5,903 km)  awayfrom
New York City, New York
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UMHAT Sv. Georgi, EAD

4000 Plovdiv, Bulgaria

Recruiting
4,791 miles (7,710 km)  awayfrom
New York City, New York
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SHAT Oncohaematology Diseases

Sofia, Bulgaria

Recruiting
4,709 miles (7,579 km)  awayfrom
New York City, New York
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MHAT Sv. Marina, EAD

bul. "Hristo Smirnenski" 1, 9010 Varna, Bulgaria

Recruiting
4,873 miles (7,843 km)  awayfrom
New York City, New York
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Kaye Edmonton Clinic

11400 University Ave, Edmonton, AB T6G 1Z1, Canada

Recruiting
2,023 miles (3,255 km)  awayfrom
New York City, New York
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McMaster Health Science

1200 Main St W, Hamilton, ON L8N 3Z5, Canada

Recruiting
350 miles (563 km)  awayfrom
New York City, New York
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Rigshospitalet Copenhagen

Blegdamsvej 9, 2100 København, Denmark

Recruiting
3,841 miles (6,181 km)  awayfrom
New York City, New York
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Helsinki Univ Hospital

Haartmaninkatu 4 Rakennus 1, 00290 Helsinki, Finland

Recruiting
4,107 miles (6,610 km)  awayfrom
New York City, New York
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Essais cliniques CHU Rennes

2 Rue Henri le Guilloux, 35000 Rennes, France

Recruiting
3,469 miles (5,583 km)  awayfrom
New York City, New York
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Hopital Necker Enfants Malades

149 Rue de Sèvres, 75015 Paris, France

Recruiting
3,622 miles (5,830 km)  awayfrom
New York City, New York
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Hopital Jeanne de Flandre - CHU Lille

Avenue Eugène Avinée, 59000 Lille, France

Recruiting
3,608 miles (5,806 km)  awayfrom
New York City, New York
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CHU de Rouen

37 Boulevard Gambetta, 76000 Rouen, France

Recruiting
3,557 miles (5,724 km)  awayfrom
New York City, New York
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Werlhof-Institut GmbH

Schillerstraße 23, 30159 Hannover, Germany

Recruiting
3,828 miles (6,161 km)  awayfrom
New York City, New York
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Inst. f. Experimentelle

Sigmund-Freud-Straße 25, 53127 Bonn, Germany

Recruiting
3,771 miles (6,068 km)  awayfrom
New York City, New York
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Klinik F.Haematologie,Onkologie

Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
3,745 miles (6,026 km)  awayfrom
New York City, New York
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Poliklinik PaediaHaematologie

Hamburg, Germany

Recruiting
3,805 miles (6,124 km)  awayfrom
New York City, New York
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The University of Hong Kong Queen Mary Hospital

Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong

Recruiting
8,050 miles (12,955 km)  awayfrom
New York City, New York
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Chinese University Of Hong Kong

The Chinese University of Hong Kong, Central Ave, Ma Liu Shui, Hong Kong

Recruiting
8,039 miles (12,938 km)  awayfrom
New York City, New York
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Belgyogyaszat Onkohaematologia

Budapest, Hungary

Recruiting
4,351 miles (7,002 km)  awayfrom
New York City, New York
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Debreceni Egyetem

Debrecen, Egyetem tér 1, 4032 Hungary

Recruiting
4,450 miles (7,162 km)  awayfrom
New York City, New York
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Presidio Ospedaliero F. Alessi

Piazza Santa Maria di Gesù, 5, 95124 Catania CT, Italy

Recruiting
4,557 miles (7,333 km)  awayfrom
New York City, New York
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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
4,157 miles (6,690 km)  awayfrom
New York City, New York
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Ospedale Maggiore Policlinico

Via Francesco Sforza, 35, 20122 Milano MI, Italy

Recruiting
4,014 miles (6,460 km)  awayfrom
New York City, New York
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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

Recruiting
4,279 miles (6,886 km)  awayfrom
New York City, New York
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Eulji University Hospital

95 Dunsanseo-ro, Dunsan-dong, Seo-gu, Daejeon, South Korea

Recruiting
6,939 miles (11,167 km)  awayfrom
New York City, New York
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Severance Hospital, Yonsei

50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea

Recruiting
6,865 miles (11,048 km)  awayfrom
New York City, New York
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Kyung Hee University Hospital

892 Dongnam-ro, Sangil-dong, Gangdong-gu, Seoul, South Korea

Recruiting
6,863 miles (11,044 km)  awayfrom
New York City, New York
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Ulsan University Hospital

877 Bangeojinsunhwan-doro, Jeonha-dong, Dong-gu, Ulsan, South Korea

Recruiting
6,960 miles (11,201 km)  awayfrom
New York City, New York
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Hospital Ampang

Hospital Ampang, Jalan Mewah Utara, Taman Pandan Mewah, 68000 Ampang Jaya, Selangor, Malaysia

Recruiting
9,392 miles (15,115 km)  awayfrom
New York City, New York
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Hospital HRPB

Jalan Raja Ashman Shah, 30450 Ipoh, Negeri Perak, Malaysia

Recruiting
9,286 miles (14,945 km)  awayfrom
New York City, New York
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Hospital Pulau Pinang

Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia

Recruiting
9,225 miles (14,846 km)  awayfrom
New York City, New York
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Hospital Kuala Lumpur

23, Jalan Pahang, 50586 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia

Recruiting
9,388 miles (15,109 km)  awayfrom
New York City, New York
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Hospital Umum Sarawak

Jalan Hospital, 93586 Kuching, Sarawak, Malaysia

Recruiting
9,500 miles (15,290 km)  awayfrom
New York City, New York
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Hospital Sultanah Nur Zahirah

20400 Kuala Terengganu, Terengganu, Malaysia

Recruiting
9,247 miles (14,881 km)  awayfrom
New York City, New York
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Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1, 9713 GZ Groningen, Netherlands

Recruiting
3,684 miles (5,928 km)  awayfrom
New York City, New York
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Oslo Universitetssykehus - Rikshospitalet

Sognsvannsveien 20, 0372 Oslo, Norway

Recruiting
3,670 miles (5,906 km)  awayfrom
New York City, New York
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NUS YLL School of Medicine

10 Medical Dr, Singapore 117597

Recruiting
9,527 miles (15,332 km)  awayfrom
New York City, New York
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KKH

100 Bukit Timah Rd, Singapore 229899

Recruiting
9,526 miles (15,331 km)  awayfrom
New York City, New York
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Hospital Univ. Son Espases

Carretera de Valldemossa, 79, 07120 Palma, Illes Balears, Spain

Site Contact
Recruiting
3,907 miles (6,288 km)  awayfrom
New York City, New York
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HOSPITAL A Coruna

Xubias de Arriba, 84, 15006 A Coruña, Spain

Recruiting
3,281 miles (5,280 km)  awayfrom
New York City, New York
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

Recruiting
3,580 miles (5,762 km)  awayfrom
New York City, New York
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Hospital Univ del Rio Hortega

Calle Dulzaina, 2, 47012 Valladolid, Spain

Recruiting
3,499 miles (5,631 km)  awayfrom
New York City, New York
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Kaohsiung Chung- Ho Memorial Hosp

No. 100號, Ziyou 1st Road, Sanmin District, Kaohsiung City, Taiwan 80756

Recruiting
7,960 miles (12,810 km)  awayfrom
New York City, New York
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China Medical University Hospital

No. 2, Yude Road, North District, Taichung City, Taiwan 404

Recruiting
7,853 miles (12,638 km)  awayfrom
New York City, New York
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Taichung Veterans General

No. 1650號, Section 4, Taiwan Boulevard, Xitun District, Taichung City, Taiwan 40705

Recruiting
7,852 miles (12,637 km)  awayfrom
New York City, New York
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Tri-Service General Hospital

No. 325號, Section 2, Chenggong Road, Neihu District, Taipei City, Taiwan 114

Recruiting
7,779 miles (12,519 km)  awayfrom
New York City, New York
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Siriraj Hospital

2 Thanon Wang Lang, Khwaeng Siriraj, Khet Bangkok Noi, Krung Thep Maha Nakhon 10700, Thailand

Recruiting
8,652 miles (13,925 km)  awayfrom
New York City, New York
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King Chulalongkorn Memorial

1873 Rama IV Rd, Khwaeng Pathum Wan, Khet Pathum Wan, Krung Thep Maha Nakhon 10330, Thailand

Recruiting
8,655 miles (13,928 km)  awayfrom
New York City, New York
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Ramathibodi Hospital

270 Thanon Rama VI, Khwaeng Thung Phaya Thai, Khet Ratchathewi, Krung Thep Maha Nakhon 10400, Thailand

Recruiting
8,652 miles (13,924 km)  awayfrom
New York City, New York
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Maharaj Nakorn Chiang Mai

110 ถนนอินทวโรรส ซอย 2 Tambon Su Thep, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50200, Thailand

Recruiting
8,297 miles (13,352 km)  awayfrom
New York City, New York
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Srinagarind Hospital

Nai Mueang, Mueang Khon Kaen District, Khon Kaen 40000, Thailand

Recruiting
8,477 miles (13,642 km)  awayfrom
New York City, New York
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Acibadem Adana Hospital

Döşeme, Cumhuriyet Cd. No:66, 01130 Seyhan/Adana, Turkey

Recruiting
5,449 miles (8,770 km)  awayfrom
New York City, New York
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Hacettepe Üniversitesi

Hacettepe, Hacettepe Ünv., 06230 Altındağ/Ankara, Turkey

Recruiting
5,215 miles (8,392 km)  awayfrom
New York City, New York
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Akdeniz Universitesi

Akdeniz Ünv., Konyaaltı/Antalya, Turkey

Recruiting
5,263 miles (8,470 km)  awayfrom
New York City, New York
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Uludag Universitesi Tip Fakültesi

Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

Recruiting
5,041 miles (8,113 km)  awayfrom
New York City, New York
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Istanbul Üniversitesi Cerrahpaşa

Cerrahpaşa, 34098 Fatih/İstanbul, Turkey

Recruiting
5,009 miles (8,062 km)  awayfrom
New York City, New York
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Ege Universitesi Tip Fakultesi

Kazımdirik, Ege Ünv. Hst. No:9, 35100 Bornova/İzmir, Turkey

Recruiting
5,050 miles (8,126 km)  awayfrom
New York City, New York
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Erciyes Univers Tip Fakultesi

Köşk Mahallesi Prof. Dr. Turhan Feyzioğlu Cad. Erciyes Üniversitesi Sağlık Uygulama ve Araştırma Merkezi No:42, Köşk, 38039 Melikgazi/Kayseri, Turkey

Recruiting
5,377 miles (8,653 km)  awayfrom
New York City, New York
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19 Mayis Universitesi

Körfez, 19 Mayıs Ünv., 55270 Atakum/Samsun, Turkey

Recruiting
5,277 miles (8,493 km)  awayfrom
New York City, New York
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MI Cherkasy Reg Onc Dis of CRC

Michigan, USA

Recruiting
640 miles (1,029 km)  awayfrom
New York City, New York
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SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

Lviv, Lviv Oblast, Ukraine, 79000

Recruiting
4,454 miles (7,169 km)  awayfrom
New York City, New York
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CI Zaporizhzhia Reg CCH of ZRC

Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

Recruiting
4,939 miles (7,949 km)  awayfrom
New York City, New York
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Royal Manchester Children's Hospital

Oxford Rd, Manchester M13 9WL, UK

Recruiting
3,334 miles (5,366 km)  awayfrom
New York City, New York
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Univ Hospital Southampton

Coxford Rd, Southampton SO16 5YA, UK

Recruiting
3,416 miles (5,498 km)  awayfrom
New York City, New York
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Bristol Royal H. for Children

Upper Maudlin St, Bristol BS2 8BJ, UK

Recruiting
3,358 miles (5,403 km)  awayfrom
New York City, New York
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Evelina Children's Hospital - St Thomas' Hospital

Westminster Bridge Rd, South Bank, London SE1 7EH, UK

Recruiting
3,458 miles (5,566 km)  awayfrom
New York City, New York
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Medizinische Universitat Wien

Spitalgasse 23, 1090 Wien, Austria

Currently On Hold
4,218 miles (6,789 km)  awayfrom
New York City, New York
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Terminated/Withdrawn
4,077 miles (6,561 km)  awayfrom
New York City, New York
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CHU CAEN Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Terminated/Withdrawn
3,500 miles (5,633 km)  awayfrom
New York City, New York
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View all (92)
Trial Protocol ID: 261203
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