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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
5,803 miles (9,340 km)  awayfrom
日本
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Kaiser Permanente Oakland M.C.

10050 N Wolfe Rd, Cupertino, CA 95014, USA

Site Contact
Recruiting
5,197 miles (8,363 km)  awayfrom
日本
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Kaiser Permanente Oakland M.C.

3600 Broadway, Oakland, CA 94611, USA

Site Contact
Recruiting
5,166 miles (8,314 km)  awayfrom
日本
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Kaiser Permanente Oakland M.C.

1600 Eureka Rd, Roseville, CA 95661, USA

Site Contact
Recruiting
5,175 miles (8,328 km)  awayfrom
日本
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UC Davis Health System

2315 Stockton Blvd, Sacramento, CA 95817, USA

Recruiting
5,173 miles (8,326 km)  awayfrom
日本
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Connecticut Children's Med Ctr

282 Washington St, Hartford, CT 06106, USA

Site Contact
Recruiting
6,687 miles (10,762 km)  awayfrom
日本
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Univ Florida College Medicine

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

Recruiting
7,158 miles (11,520 km)  awayfrom
日本
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Center for Advanced Pediatrics

1400 Tullie Rd NE, Atlanta, GA 30329, USA

Recruiting
6,852 miles (11,027 km)  awayfrom
日本
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Ann & Robert H. Lurie Children's H

225 E Chicago Ave, Chicago, IL 60611, USA

Recruiting
6,291 miles (10,125 km)  awayfrom
日本
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Bleeding and Clotting Dis.Inst.

9128 N Lindbergh Dr, Peoria, IL 61615, USA

Recruiting
6,292 miles (10,125 km)  awayfrom
日本
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UMHS

2903 Baxter Rd, Ann Arbor, MI 48109, USA

Recruiting
6,381 miles (10,270 km)  awayfrom
日本
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New York Presbyterian Hospital

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

Recruiting
6,721 miles (10,816 km)  awayfrom
日本
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Novant Health Presbyterian Medical Center

200 Hawthorne Ln, Charlotte, NC 28204, USA

Recruiting
6,879 miles (11,070 km)  awayfrom
日本
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Wake Forest Baptist Medical Center

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

Recruiting
6,843 miles (11,012 km)  awayfrom
日本
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Cincinnati Children's Hospital

3333 Burnet Ave, Cincinnati, OH 45229, USA

Recruiting
6,541 miles (10,527 km)  awayfrom
日本
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Rainbow Babies/Childrens Htl

11100 Euclid Ave, Cleveland, OH 44106, USA

Recruiting
6,485 miles (10,437 km)  awayfrom
日本
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Penn State MS Hershey Med Ctr

500 University Dr, Hershey, PA 17033, USA

Recruiting
6,687 miles (10,761 km)  awayfrom
日本
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Texas Tech University Health Sciences Center

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

Recruiting
6,125 miles (9,858 km)  awayfrom
日本
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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

Recruiting
6,683 miles (10,755 km)  awayfrom
日本
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Primary Children's Hospital

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

Recruiting
5,489 miles (8,833 km)  awayfrom
日本
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HUDERF

Avenue Jean Joseph Crocq 15, 1020 Bruxelles, Belgium

Recruiting
5,798 miles (9,331 km)  awayfrom
日本
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Cliniques Uni Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

Recruiting
5,797 miles (9,330 km)  awayfrom
日本
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Univ. Ziekenhuis Gent Apotheek

Zwijnaardsesteenweg 566, 9000 Gent, Belgium

Recruiting
5,806 miles (9,344 km)  awayfrom
日本
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Universitair Ziekenhuis Leuven

Herestraat 49, 3000 Leuven, Belgium

Recruiting
5,790 miles (9,318 km)  awayfrom
日本
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UMHAT Sv. Georgi, EAD

4000 Plovdiv, Bulgaria

Recruiting
5,595 miles (9,004 km)  awayfrom
日本
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SHAT Oncohaematology Diseases

Sofia, Bulgaria

Recruiting
5,623 miles (9,050 km)  awayfrom
日本
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MHAT Sv. Marina, EAD

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

Recruiting
5,424 miles (8,728 km)  awayfrom
日本
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Kaye Edmonton Clinic

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

Recruiting
4,887 miles (7,864 km)  awayfrom
日本
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McMaster Health Science

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

Recruiting
6,425 miles (10,340 km)  awayfrom
日本
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Rigshospitalet Copenhagen

Blegdamsvej 9, 2100 København, Denmark

Recruiting
5,327 miles (8,573 km)  awayfrom
日本
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Helsinki Univ Hospital

Haartmaninkatu 4 Rakennus 1, 00290 Helsinki, Finland

Recruiting
4,786 miles (7,702 km)  awayfrom
日本
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Essais cliniques CHU Rennes

2 Rue Henri le Guilloux, 35000 Rennes, France

Recruiting
6,106 miles (9,827 km)  awayfrom
日本
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Hopital Necker Enfants Malades

149 Rue de Sèvres, 75015 Paris, France

Recruiting
5,965 miles (9,600 km)  awayfrom
日本
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Hopital Jeanne de Flandre - CHU Lille

Avenue Eugène Avinée, 59000 Lille, France

Recruiting
5,847 miles (9,410 km)  awayfrom
日本
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CHU de Rouen

37 Boulevard Gambetta, 76000 Rouen, France

Recruiting
5,961 miles (9,594 km)  awayfrom
日本
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Werlhof-Institut GmbH

Schillerstraße 23, 30159 Hannover, Germany

Recruiting
5,576 miles (8,973 km)  awayfrom
日本
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Inst. f. Experimentelle

Sigmund-Freud-Straße 25, 53127 Bonn, Germany

Recruiting
5,737 miles (9,232 km)  awayfrom
日本
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Klinik F.Haematologie,Onkologie

Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
5,718 miles (9,202 km)  awayfrom
日本
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Poliklinik PaediaHaematologie

Hamburg, Germany

Recruiting
5,506 miles (8,862 km)  awayfrom
日本
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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
1,759 miles (2,830 km)  awayfrom
日本
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Chinese University Of Hong Kong

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

Recruiting
1,748 miles (2,814 km)  awayfrom
日本
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Belgyogyaszat Onkohaematologia

Budapest, Hungary

Recruiting
5,545 miles (8,925 km)  awayfrom
日本
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Debreceni Egyetem

Debrecen, Egyetem tér 1, 4032 Hungary

Recruiting
5,456 miles (8,781 km)  awayfrom
日本
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Presidio Ospedaliero F. Alessi

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

Recruiting
6,184 miles (9,952 km)  awayfrom
日本
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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
5,987 miles (9,636 km)  awayfrom
日本
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Ospedale Maggiore Policlinico

Via Francesco Sforza, 35, 20122 Milano MI, Italy

Recruiting
5,963 miles (9,596 km)  awayfrom
日本
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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

Recruiting
6,046 miles (9,731 km)  awayfrom
日本
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Eulji University Hospital

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

Recruiting
623 miles (1,003 km)  awayfrom
日本
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Severance Hospital, Yonsei

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

Recruiting
648 miles (1,043 km)  awayfrom
日本
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Kyung Hee University Hospital

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

Recruiting
636 miles (1,023 km)  awayfrom
日本
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Ulsan University Hospital

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

Recruiting
516 miles (830 km)  awayfrom
日本
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Hospital Ampang

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

Recruiting
3,281 miles (5,280 km)  awayfrom
日本
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Hospital HRPB

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

Recruiting
3,235 miles (5,206 km)  awayfrom
日本
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Hospital Pulau Pinang

Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia

Recruiting
3,230 miles (5,199 km)  awayfrom
日本
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Hospital Kuala Lumpur

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

Recruiting
3,281 miles (5,281 km)  awayfrom
日本
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Hospital Umum Sarawak

Jalan Hospital, 93586 Kuching, Sarawak, Malaysia

Recruiting
3,008 miles (4,842 km)  awayfrom
日本
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Hospital Sultanah Nur Zahirah

20400 Kuala Terengganu, Terengganu, Malaysia

Recruiting
3,104 miles (4,995 km)  awayfrom
日本
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Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1, 9713 GZ Groningen, Netherlands

Recruiting
5,612 miles (9,032 km)  awayfrom
日本
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Oslo Universitetssykehus - Rikshospitalet

Sognsvannsveien 20, 0372 Oslo, Norway

Recruiting
5,152 miles (8,292 km)  awayfrom
日本
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NUS YLL School of Medicine

10 Medical Dr, Singapore 117597

Recruiting
3,289 miles (5,293 km)  awayfrom
日本
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KKH

100 Bukit Timah Rd, Singapore 229899

Recruiting
3,286 miles (5,288 km)  awayfrom
日本
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Hospital Univ. Son Espases

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

Site Contact
Recruiting
6,486 miles (10,438 km)  awayfrom
日本
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HOSPITAL A Coruna

Xubias de Arriba, 84, 15006 A Coruña, Spain

Recruiting
6,550 miles (10,541 km)  awayfrom
日本
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

Recruiting
6,612 miles (10,640 km)  awayfrom
日本
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Hospital Univ del Rio Hortega

Calle Dulzaina, 2, 47012 Valladolid, Spain

Recruiting
6,568 miles (10,571 km)  awayfrom
日本
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Kaohsiung Chung- Ho Memorial Hosp

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

Recruiting
1,448 miles (2,330 km)  awayfrom
日本
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China Medical University Hospital

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

Recruiting
1,358 miles (2,186 km)  awayfrom
日本
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Taichung Veterans General

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

Recruiting
1,361 miles (2,190 km)  awayfrom
日本
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Tri-Service General Hospital

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

Recruiting
1,273 miles (2,049 km)  awayfrom
日本
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Siriraj Hospital

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

Recruiting
2,823 miles (4,543 km)  awayfrom
日本
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King Chulalongkorn Memorial

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

Recruiting
2,821 miles (4,540 km)  awayfrom
日本
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Ramathibodi Hospital

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

Recruiting
2,820 miles (4,539 km)  awayfrom
日本
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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
2,688 miles (4,326 km)  awayfrom
日本
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Srinagarind Hospital

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

Recruiting
2,583 miles (4,156 km)  awayfrom
日本
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Acibadem Adana Hospital

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

Recruiting
5,383 miles (8,664 km)  awayfrom
日本
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Hacettepe Üniversitesi

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

Recruiting
5,367 miles (8,637 km)  awayfrom
日本
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Akdeniz Universitesi

Akdeniz Ünv., Konyaaltı/Antalya, Turkey

Recruiting
5,591 miles (8,997 km)  awayfrom
日本
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Uludag Universitesi Tip Fakültesi

Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

Recruiting
5,519 miles (8,882 km)  awayfrom
日本
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Istanbul Üniversitesi Cerrahpaşa

Cerrahpaşa, 34098 Fatih/İstanbul, Turkey

Recruiting
5,482 miles (8,822 km)  awayfrom
日本
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Ege Universitesi Tip Fakultesi

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

Recruiting
5,666 miles (9,118 km)  awayfrom
日本
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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
5,304 miles (8,536 km)  awayfrom
日本
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19 Mayis Universitesi

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

Recruiting
5,167 miles (8,316 km)  awayfrom
日本
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MI Cherkasy Reg Onc Dis of CRC

Michigan, USA

Recruiting
6,212 miles (9,998 km)  awayfrom
日本
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SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

Lviv, Lviv Oblast, Ukraine, 79000

Recruiting
5,269 miles (8,479 km)  awayfrom
日本
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CI Zaporizhzhia Reg CCH of ZRC

Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

Recruiting
4,954 miles (7,972 km)  awayfrom
日本
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Royal Manchester Children's Hospital

Oxford Rd, Manchester M13 9WL, UK

Recruiting
5,801 miles (9,336 km)  awayfrom
日本
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Univ Hospital Southampton

Coxford Rd, Southampton SO16 5YA, UK

Recruiting
5,934 miles (9,549 km)  awayfrom
日本
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Bristol Royal H. for Children

Upper Maudlin St, Bristol BS2 8BJ, UK

Recruiting
5,928 miles (9,541 km)  awayfrom
日本
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Evelina Children's Hospital - St Thomas' Hospital

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

Recruiting
5,871 miles (9,448 km)  awayfrom
日本
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Medizinische Universitat Wien

Spitalgasse 23, 1090 Wien, Austria

Currently On Hold
5,597 miles (9,008 km)  awayfrom
日本
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

5,565 miles (8,957 km)  awayfrom
日本
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CHU CAEN Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

6,010 miles (9,673 km)  awayfrom
日本
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View all (92)
Trial Protocol ID: 261203
Back to Trial Summary

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