A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A

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

This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study.

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, ITI
How many participants are being enrolled?   120
When is the trial being conducted?    - 
How long is participation in the trial?   Participants will stay in the study for up to 2 years. Participants may be contacted by their study doctor for up to 3 months after they have completed the study for additional information. Participants who benefit from BAX 855 may stay in the study for longer and continue to receive this medicine until the medicine is available commercially or has not been licensed in the participant’s country at the time the study is completed globally.

Key requirements

Sex   
All
Age   
Up to 5 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:   
Previously untreated patients (PUPs): Part A (Main Study): Participants age <3 years and not experienced two joint bleeds will receive on- demand treatment of 10-80 international unit per kilogram (IU/kg) of BAX 855 intravenously depending on the severity of the bleeding episode and age <3 years or after a maximum of two joint bleeds will receive prophylaxis treatment with dose of 25-80 IU/kg of BAX855 IV (based on investigator discretion) once weekly for up to 100 EDs. Part A (Surgery): In participants, the administration of BAX 855 will be individualized based on the participants IR and half-life. For major surgery to achieve the target level of 80-100% FVIII in plasma of normal FVIII level and for minor surgery >=30-60% FVIII levels for dental or other invasive surgery. Part B (Immune tolerance induction [ITI]): Participants will receive prophylaxis treatment of 100-200 IU/kg BAX 855 IV daily or 50 IU/kg three time in a week and will be reduced to twice weekly to maintain FVIII trough level of 1% for further 3 months.
Intervention:   PEGylated Recombinant Factor VIII, ITI
Primary Outcome Measure(s):   
Number of Participants With 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]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Throughout Part A and Part B of the study, approximately 7 years]
Number of Participants With Clinically Significant Changes in Vital Signs [Time Frame: Throughout Part A and Part B of the study, approximately 7 years]
Number of Participants With 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 Needed for the Treatment of Bleeding Episodes [Time Frame: Throughout Part A of the study, approximately 5 years]
Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Initiation of Treatment [Time Frame: 24 hours after study drug administration]
Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution [Time Frame: From start of study treatment up to bleed resolution (approximately 5 years)]
Number of Participants With Weight-adjusted Consumption of BAX 855 [Time Frame: Throughout Part A of the study, approximately 5 years]
Number of Infusions During Weight-adjusted Consumption of BAX 855 [Time Frame: Throughout Part A of the study, approximately 5 years]
Number of Participants With Hemostatic Efficacy in Case of Surgery [Time Frame: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)]
Blood Loss Per Participant in Case of Surgery [Time Frame: Surgery Day 0 up to postoperative Day 14 or discharge (whichever occurs first)]
Incremental Recovery (IR) of BAX 855 [Time Frame: Pre-infusion within 30 minutes; and post-infusion at 15-30 minutes and 24-48 hours]
Half-life (T1/2) of BAX 855 [Time Frame: Pre-infusion, 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) [Time Frame: Up to 33 months]
Immune Tolerance Induction (ITI) - Weight-adjusted Consumption of BAX 855 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:
- Children 6 years or younger can take part. - Must have severe hemophilia A - Must not have been previously treated with BAX855 or other FVIII concentrates. - Cannot have been diagnosed with a bleeding condition other than hemophilia A Additional entry criteria will be discussed with the study doctor.

Trial Locations

Any
Recruiting
Suspended
Withdrawn
Any
RESULTS
Phoenix Childrens Hospital

1919 E Thomas Rd, Phoenix, AZ 85016, USA

Recruiting
6,257 miles (10,069 km)  awayfrom
Новосибирск, Новосибирская область
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Kaiser Permanente Oakland M.C.

10050 N Wolfe Rd, Cupertino, CA 95014, USA

Site Contact
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5,887 miles (9,474 km)  awayfrom
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Kaiser Permanente Oakland M.C.

3600 Broadway, Oakland, CA 94611, USA

Site Contact
Recruiting
5,850 miles (9,415 km)  awayfrom
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Kaiser Permanente Oakland M.C.

1600 Eureka Rd, Roseville, CA 95661, USA

Site Contact
Recruiting
5,801 miles (9,336 km)  awayfrom
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UC Davis Health System

2315 Stockton Blvd, Sacramento, CA 95817, USA

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5,812 miles (9,353 km)  awayfrom
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Connecticut Children's Med Ctr

282 Washington St, Hartford, CT 06106, USA

Site Contact
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5,597 miles (9,007 km)  awayfrom
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Univ Florida College Medicine

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

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6,522 miles (10,495 km)  awayfrom
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Center for Advanced Pediatrics

1400 Tullie Rd NE, Atlanta, GA 30329, USA

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6,250 miles (10,058 km)  awayfrom
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Ann & Robert H. Lurie Children's H

225 E Chicago Ave, Chicago, IL 60611, USA

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5,716 miles (9,199 km)  awayfrom
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Bleeding and Clotting Dis.Inst.

9128 N Lindbergh Dr, Peoria, IL 61615, USA

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5,800 miles (9,335 km)  awayfrom
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UMHS

2903 Baxter Rd, Ann Arbor, MI 48109, USA

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5,666 miles (9,118 km)  awayfrom
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New York Presbyterian Hospital

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

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5,678 miles (9,139 km)  awayfrom
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Novant Health Presbyterian Medical Center

200 Hawthorne Ln, Charlotte, NC 28204, USA

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6,127 miles (9,860 km)  awayfrom
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Wake Forest Baptist Medical Center

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

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6,062 miles (9,756 km)  awayfrom
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Cincinnati Children's Hospital

3333 Burnet Ave, Cincinnati, OH 45229, USA

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5,887 miles (9,475 km)  awayfrom
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Rainbow Babies/Childrens Htl

11100 Euclid Ave, Cleveland, OH 44106, USA

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5,704 miles (9,180 km)  awayfrom
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Penn State MS Hershey Med Ctr

500 University Dr, Hershey, PA 17033, USA

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5,743 miles (9,242 km)  awayfrom
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Texas Tech University Health Sciences Center

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

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6,413 miles (10,321 km)  awayfrom
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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

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6,581 miles (10,590 km)  awayfrom
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Primary Children's Hospital

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

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5,760 miles (9,270 km)  awayfrom
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HUDERF

Avenue Jean Joseph Crocq 15, 1020 Bruxelles, Belgium

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3,107 miles (5,001 km)  awayfrom
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Cliniques Uni Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

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3,105 miles (4,997 km)  awayfrom
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Univ. Ziekenhuis Gent Apotheek

Zwijnaardsesteenweg 566, 9000 Gent, Belgium

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3,123 miles (5,026 km)  awayfrom
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Universitair Ziekenhuis Leuven

Herestraat 49, 3000 Leuven, Belgium

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3,096 miles (4,982 km)  awayfrom
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UMHAT Sv. Georgi, EAD

4000 Plovdiv, Bulgaria

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2,714 miles (4,368 km)  awayfrom
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SHAT Oncohaematology Diseases

Sofia, Bulgaria

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2,746 miles (4,419 km)  awayfrom
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MHAT Sv. Marina, EAD

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

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2,541 miles (4,090 km)  awayfrom
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Kaye Edmonton Clinic

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

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4,878 miles (7,850 km)  awayfrom
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McMaster Health Science

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

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5,571 miles (8,965 km)  awayfrom
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Rigshospitalet Copenhagen

Blegdamsvej 9, 2100 København, Denmark

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2,641 miles (4,251 km)  awayfrom
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Helsinki Univ Hospital

Haartmaninkatu 4 Rakennus 1, 00290 Helsinki, Finland

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2,105 miles (3,387 km)  awayfrom
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CHU CAEN Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

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3,342 miles (5,379 km)  awayfrom
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Essais cliniques CHU Rennes

2 Rue Henri le Guilloux, 35000 Rennes, France

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3,438 miles (5,532 km)  awayfrom
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Hopital Necker Enfants Malades

149 Rue de Sèvres, 75015 Paris, France

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3,266 miles (5,255 km)  awayfrom
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Hopital Jeanne de Flandre - CHU Lille

Avenue Eugène Avinée, 59000 Lille, France

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3,164 miles (5,092 km)  awayfrom
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CHU de Rouen

37 Boulevard Gambetta, 76000 Rouen, France

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3,281 miles (5,281 km)  awayfrom
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Werlhof-Institut GmbH

Schillerstraße 23, 30159 Hannover, Germany

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2,859 miles (4,601 km)  awayfrom
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Inst. f. Experimentelle

Sigmund-Freud-Straße 25, 53127 Bonn, Germany

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3,018 miles (4,858 km)  awayfrom
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Klinik F.Haematologie,Onkologie

Moorenstraße 5, 40225 Düsseldorf, Germany

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3,009 miles (4,843 km)  awayfrom
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Poliklinik PaediaHaematologie

Hamburg, Germany

Recruiting
2,806 miles (4,515 km)  awayfrom
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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

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2,775 miles (4,466 km)  awayfrom
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Chinese University Of Hong Kong

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

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2,768 miles (4,455 km)  awayfrom
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Belgyogyaszat Onkohaematologia

Budapest, Hungary

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2,710 miles (4,362 km)  awayfrom
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Debreceni Egyetem

Debrecen, Egyetem tér 1, 4032 Hungary

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2,610 miles (4,200 km)  awayfrom
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Presidio Ospedaliero F. Alessi

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

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3,309 miles (5,325 km)  awayfrom
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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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3,163 miles (5,091 km)  awayfrom
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Ospedale Maggiore Policlinico

Via Francesco Sforza, 35, 20122 Milano MI, Italy

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3,167 miles (5,096 km)  awayfrom
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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

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3,202 miles (5,152 km)  awayfrom
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Eulji University Hospital

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

Recruiting
2,445 miles (3,936 km)  awayfrom
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Severance Hospital, Yonsei

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

Recruiting
2,369 miles (3,812 km)  awayfrom
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Kyung Hee University Hospital

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

Recruiting
2,378 miles (3,826 km)  awayfrom
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Ulsan University Hospital

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

Recruiting
2,566 miles (4,130 km)  awayfrom
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Hospital Ampang

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

Recruiting
3,738 miles (6,016 km)  awayfrom
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Hospital HRPB

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

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3,629 miles (5,840 km)  awayfrom
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Hospital Pulau Pinang

Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia

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3,562 miles (5,732 km)  awayfrom
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Hospital Kuala Lumpur

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

Recruiting
3,734 miles (6,010 km)  awayfrom
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Hospital Umum Sarawak

Jalan Hospital, 93586 Kuching, Sarawak, Malaysia

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4,004 miles (6,444 km)  awayfrom
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Hospital Sultanah Nur Zahirah

20400 Kuala Terengganu, Terengganu, Malaysia

Recruiting
3,614 miles (5,816 km)  awayfrom
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Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1, 9713 GZ Groningen, Netherlands

Recruiting
2,936 miles (4,724 km)  awayfrom
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Oslo Universitetssykehus - Rikshospitalet

Sognsvannsveien 20, 0372 Oslo, Norway

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2,567 miles (4,131 km)  awayfrom
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NUS YLL School of Medicine

10 Medical Dr, Singapore 117597

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3,894 miles (6,267 km)  awayfrom
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KKH

100 Bukit Timah Rd, Singapore 229899

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3,894 miles (6,267 km)  awayfrom
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Hospital Univ. Son Espases

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

Site Contact
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3,685 miles (5,931 km)  awayfrom
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HOSPITAL A Coruna

Xubias de Arriba, 84, 15006 A Coruña, Spain

Recruiting
3,898 miles (6,274 km)  awayfrom
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

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3,876 miles (6,237 km)  awayfrom
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Hospital Univ del Rio Hortega

Calle Dulzaina, 2, 47012 Valladolid, Spain

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3,855 miles (6,204 km)  awayfrom
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Kaohsiung Chung- Ho Memorial Hosp

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

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2,945 miles (4,740 km)  awayfrom
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China Medical University Hospital

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

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2,868 miles (4,616 km)  awayfrom
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Taichung Veterans General

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

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2,864 miles (4,610 km)  awayfrom
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Tri-Service General Hospital

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

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2,846 miles (4,580 km)  awayfrom
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Siriraj Hospital

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

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3,004 miles (4,835 km)  awayfrom
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King Chulalongkorn Memorial

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

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3,007 miles (4,839 km)  awayfrom
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Ramathibodi Hospital

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

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3,004 miles (4,835 km)  awayfrom
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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

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2,642 miles (4,253 km)  awayfrom
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Srinagarind Hospital

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

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2,867 miles (4,614 km)  awayfrom
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Acibadem Adana Hospital

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

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2,536 miles (4,081 km)  awayfrom
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Hacettepe Üniversitesi

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

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2,493 miles (4,012 km)  awayfrom
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Akdeniz Universitesi

Akdeniz Ünv., Konyaaltı/Antalya, Turkey

Recruiting
2,724 miles (4,383 km)  awayfrom
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Uludag Universitesi Tip Fakültesi

Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

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2,638 miles (4,245 km)  awayfrom
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Istanbul Üniversitesi Cerrahpaşa

Cerrahpaşa, 34098 Fatih/İstanbul, Turkey

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2,599 miles (4,183 km)  awayfrom
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Ege Universitesi Tip Fakultesi

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

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2,785 miles (4,482 km)  awayfrom
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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
2,445 miles (3,935 km)  awayfrom
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19 Mayis Universitesi

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

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2,296 miles (3,695 km)  awayfrom
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MI Cherkasy Reg Onc Dis of CRC

Michigan, USA

Recruiting
5,539 miles (8,915 km)  awayfrom
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SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

Lviv, Lviv Oblast, Ukraine, 79000

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2,431 miles (3,912 km)  awayfrom
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CI Zaporizhzhia Reg CCH of ZRC

Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

Recruiting
2,073 miles (3,337 km)  awayfrom
Новосибирск, Новосибирская область
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Royal Manchester Children's Hospital

Oxford Rd, Manchester M13 9WL, UK

Recruiting
3,218 miles (5,179 km)  awayfrom
Новосибирск, Новосибирская область
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Univ Hospital Southampton

Coxford Rd, Southampton SO16 5YA, UK

Recruiting
3,302 miles (5,314 km)  awayfrom
Новосибирск, Новосибирская область
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Bristol Royal H. for Children

Upper Maudlin St, Bristol BS2 8BJ, UK

Recruiting
3,318 miles (5,339 km)  awayfrom
Новосибирск, Новосибирская область
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Evelina Children's Hospital - St Thomas' Hospital

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

Recruiting
3,233 miles (5,203 km)  awayfrom
Новосибирск, Новосибирская область
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Medizinische Universitat Wien

Spitalgasse 23, 1090 Wien, Austria

Currently On Hold
2,783 miles (4,478 km)  awayfrom
Новосибирск, Новосибирская область
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Terminated/Withdrawn
2,784 miles (4,480 km)  awayfrom
Новосибирск, Новосибирская область
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View all (92)
Trial Protocol ID: 261203
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