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
2,292 miles (3,689 km)  awayfrom
Boston, Massachusetts
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Kaiser Permanente Oakland M.C.

10050 N Wolfe Rd, Cupertino, CA 95014, USA

Site Contact
Recruiting
2,685 miles (4,321 km)  awayfrom
Boston, Massachusetts
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Kaiser Permanente Oakland M.C.

3600 Broadway, Oakland, CA 94611, USA

Site Contact
Recruiting
2,683 miles (4,318 km)  awayfrom
Boston, Massachusetts
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Kaiser Permanente Oakland M.C.

1600 Eureka Rd, Roseville, CA 95661, USA

Site Contact
Recruiting
2,608 miles (4,197 km)  awayfrom
Boston, Massachusetts
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UC Davis Health System

2315 Stockton Blvd, Sacramento, CA 95817, USA

Recruiting
2,623 miles (4,222 km)  awayfrom
Boston, Massachusetts
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Connecticut Children's Med Ctr

282 Washington St, Hartford, CT 06106, USA

Site Contact
Recruiting
93 miles (150 km)  awayfrom
Boston, Massachusetts
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Univ Florida College Medicine

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

Recruiting
1,080 miles (1,738 km)  awayfrom
Boston, Massachusetts
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Center for Advanced Pediatrics

1400 Tullie Rd NE, Atlanta, GA 30329, USA

Recruiting
930 miles (1,496 km)  awayfrom
Boston, Massachusetts
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Ann & Robert H. Lurie Children's H

225 E Chicago Ave, Chicago, IL 60611, USA

Recruiting
848 miles (1,365 km)  awayfrom
Boston, Massachusetts
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Bleeding and Clotting Dis.Inst.

9128 N Lindbergh Dr, Peoria, IL 61615, USA

Recruiting
963 miles (1,549 km)  awayfrom
Boston, Massachusetts
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UMHS

2903 Baxter Rd, Ann Arbor, MI 48109, USA

Recruiting
645 miles (1,038 km)  awayfrom
Boston, Massachusetts
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New York Presbyterian Hospital

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

Recruiting
186 miles (299 km)  awayfrom
Boston, Massachusetts
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Novant Health Presbyterian Medical Center

200 Hawthorne Ln, Charlotte, NC 28204, USA

Recruiting
721 miles (1,160 km)  awayfrom
Boston, Massachusetts
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Wake Forest Baptist Medical Center

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

Recruiting
656 miles (1,055 km)  awayfrom
Boston, Massachusetts
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Cincinnati Children's Hospital

3333 Burnet Ave, Cincinnati, OH 45229, USA

Recruiting
737 miles (1,186 km)  awayfrom
Boston, Massachusetts
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Rainbow Babies/Childrens Htl

11100 Euclid Ave, Cleveland, OH 44106, USA

Recruiting
545 miles (877 km)  awayfrom
Boston, Massachusetts
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Penn State MS Hershey Med Ctr

500 University Dr, Hershey, PA 17033, USA

Recruiting
325 miles (524 km)  awayfrom
Boston, Massachusetts
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Texas Tech University Health Sciences Center

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

Recruiting
2,065 miles (3,323 km)  awayfrom
Boston, Massachusetts
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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

Recruiting
1,608 miles (2,587 km)  awayfrom
Boston, Massachusetts
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Primary Children's Hospital

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

Recruiting
2,091 miles (3,364 km)  awayfrom
Boston, Massachusetts
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HUDERF

Avenue Jean Joseph Crocq 15, 1020 Bruxelles, Belgium

Recruiting
3,467 miles (5,579 km)  awayfrom
Boston, Massachusetts
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Cliniques Uni Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

Recruiting
3,473 miles (5,589 km)  awayfrom
Boston, Massachusetts
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Univ. Ziekenhuis Gent Apotheek

Zwijnaardsesteenweg 566, 9000 Gent, Belgium

Recruiting
3,439 miles (5,534 km)  awayfrom
Boston, Massachusetts
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Universitair Ziekenhuis Leuven

Herestraat 49, 3000 Leuven, Belgium

Recruiting
3,481 miles (5,602 km)  awayfrom
Boston, Massachusetts
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UMHAT Sv. Georgi, EAD

4000 Plovdiv, Bulgaria

Recruiting
4,604 miles (7,409 km)  awayfrom
Boston, Massachusetts
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SHAT Oncohaematology Diseases

Sofia, Bulgaria

Recruiting
4,522 miles (7,278 km)  awayfrom
Boston, Massachusetts
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MHAT Sv. Marina, EAD

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

Recruiting
4,687 miles (7,542 km)  awayfrom
Boston, Massachusetts
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Kaye Edmonton Clinic

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

Recruiting
2,074 miles (3,338 km)  awayfrom
Boston, Massachusetts
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McMaster Health Science

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

Recruiting
453 miles (729 km)  awayfrom
Boston, Massachusetts
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Rigshospitalet Copenhagen

Blegdamsvej 9, 2100 København, Denmark

Recruiting
3,657 miles (5,885 km)  awayfrom
Boston, Massachusetts
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Helsinki Univ Hospital

Haartmaninkatu 4 Rakennus 1, 00290 Helsinki, Finland

Recruiting
3,930 miles (6,324 km)  awayfrom
Boston, Massachusetts
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CHU CAEN Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Recruiting
3,314 miles (5,333 km)  awayfrom
Boston, Massachusetts
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Essais cliniques CHU Rennes

2 Rue Henri le Guilloux, 35000 Rennes, France

Recruiting
3,282 miles (5,282 km)  awayfrom
Boston, Massachusetts
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Hopital Necker Enfants Malades

149 Rue de Sèvres, 75015 Paris, France

Recruiting
3,435 miles (5,529 km)  awayfrom
Boston, Massachusetts
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Hopital Jeanne de Flandre - CHU Lille

Avenue Eugène Avinée, 59000 Lille, France

Recruiting
3,421 miles (5,506 km)  awayfrom
Boston, Massachusetts
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CHU de Rouen

37 Boulevard Gambetta, 76000 Rouen, France

Recruiting
3,370 miles (5,423 km)  awayfrom
Boston, Massachusetts
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Werlhof-Institut GmbH

Schillerstraße 23, 30159 Hannover, Germany

Recruiting
3,642 miles (5,861 km)  awayfrom
Boston, Massachusetts
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Inst. f. Experimentelle

Sigmund-Freud-Straße 25, 53127 Bonn, Germany

Recruiting
3,584 miles (5,768 km)  awayfrom
Boston, Massachusetts
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Klinik F.Haematologie,Onkologie

Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
3,558 miles (5,726 km)  awayfrom
Boston, Massachusetts
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Poliklinik PaediaHaematologie

Hamburg, Germany

Recruiting
3,620 miles (5,825 km)  awayfrom
Boston, Massachusetts
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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
7,959 miles (12,808 km)  awayfrom
Boston, Massachusetts
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Chinese University Of Hong Kong

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

Recruiting
7,948 miles (12,791 km)  awayfrom
Boston, Massachusetts
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Belgyogyaszat Onkohaematologia

Budapest, Hungary

Recruiting
4,164 miles (6,702 km)  awayfrom
Boston, Massachusetts
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Debreceni Egyetem

Debrecen, Egyetem tér 1, 4032 Hungary

Recruiting
4,264 miles (6,862 km)  awayfrom
Boston, Massachusetts
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Presidio Ospedaliero F. Alessi

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

Recruiting
4,371 miles (7,035 km)  awayfrom
Boston, Massachusetts
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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
3,970 miles (6,390 km)  awayfrom
Boston, Massachusetts
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Ospedale Maggiore Policlinico

Via Francesco Sforza, 35, 20122 Milano MI, Italy

Recruiting
3,827 miles (6,159 km)  awayfrom
Boston, Massachusetts
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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

Recruiting
4,092 miles (6,586 km)  awayfrom
Boston, Massachusetts
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Eulji University Hospital

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

Recruiting
6,875 miles (11,064 km)  awayfrom
Boston, Massachusetts
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Severance Hospital, Yonsei

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

Recruiting
6,799 miles (10,942 km)  awayfrom
Boston, Massachusetts
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Kyung Hee University Hospital

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

Recruiting
6,797 miles (10,939 km)  awayfrom
Boston, Massachusetts
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Ulsan University Hospital

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

Recruiting
6,902 miles (11,108 km)  awayfrom
Boston, Massachusetts
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Hospital Ampang

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

Recruiting
9,261 miles (14,905 km)  awayfrom
Boston, Massachusetts
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Hospital HRPB

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

Recruiting
9,154 miles (14,733 km)  awayfrom
Boston, Massachusetts
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Hospital Pulau Pinang

Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia

Recruiting
9,091 miles (14,630 km)  awayfrom
Boston, Massachusetts
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Hospital Kuala Lumpur

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

Recruiting
9,258 miles (14,899 km)  awayfrom
Boston, Massachusetts
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Hospital Umum Sarawak

Jalan Hospital, 93586 Kuching, Sarawak, Malaysia

Recruiting
9,402 miles (15,130 km)  awayfrom
Boston, Massachusetts
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Hospital Sultanah Nur Zahirah

20400 Kuala Terengganu, Terengganu, Malaysia

Recruiting
9,122 miles (14,680 km)  awayfrom
Boston, Massachusetts
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Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1, 9713 GZ Groningen, Netherlands

Recruiting
3,498 miles (5,629 km)  awayfrom
Boston, Massachusetts
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Oslo Universitetssykehus - Rikshospitalet

Sognsvannsveien 20, 0372 Oslo, Norway

Recruiting
3,489 miles (5,614 km)  awayfrom
Boston, Massachusetts
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NUS YLL School of Medicine

10 Medical Dr, Singapore 117597

Recruiting
9,403 miles (15,132 km)  awayfrom
Boston, Massachusetts
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KKH

100 Bukit Timah Rd, Singapore 229899

Recruiting
9,402 miles (15,132 km)  awayfrom
Boston, Massachusetts
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Hospital Univ. Son Espases

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

Site Contact
Recruiting
3,724 miles (5,992 km)  awayfrom
Boston, Massachusetts
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HOSPITAL A Coruna

Xubias de Arriba, 84, 15006 A Coruña, Spain

Recruiting
3,098 miles (4,985 km)  awayfrom
Boston, Massachusetts
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

Recruiting
3,398 miles (5,468 km)  awayfrom
Boston, Massachusetts
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Hospital Univ del Rio Hortega

Calle Dulzaina, 2, 47012 Valladolid, Spain

Recruiting
3,316 miles (5,336 km)  awayfrom
Boston, Massachusetts
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Kaohsiung Chung- Ho Memorial Hosp

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

Recruiting
7,887 miles (12,692 km)  awayfrom
Boston, Massachusetts
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China Medical University Hospital

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

Recruiting
7,780 miles (12,520 km)  awayfrom
Boston, Massachusetts
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Taichung Veterans General

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

Recruiting
7,779 miles (12,519 km)  awayfrom
Boston, Massachusetts
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Tri-Service General Hospital

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

Recruiting
7,708 miles (12,405 km)  awayfrom
Boston, Massachusetts
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Siriraj Hospital

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

Recruiting
8,522 miles (13,714 km)  awayfrom
Boston, Massachusetts
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King Chulalongkorn Memorial

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

Recruiting
8,524 miles (13,718 km)  awayfrom
Boston, Massachusetts
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Ramathibodi Hospital

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

Recruiting
8,522 miles (13,714 km)  awayfrom
Boston, Massachusetts
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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
8,164 miles (13,138 km)  awayfrom
Boston, Massachusetts
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Srinagarind Hospital

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

Recruiting
8,353 miles (13,443 km)  awayfrom
Boston, Massachusetts
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Acibadem Adana Hospital

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

Recruiting
5,262 miles (8,469 km)  awayfrom
Boston, Massachusetts
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Hacettepe Üniversitesi

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

Recruiting
5,028 miles (8,092 km)  awayfrom
Boston, Massachusetts
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Akdeniz Universitesi

Akdeniz Ünv., Konyaaltı/Antalya, Turkey

Recruiting
5,076 miles (8,169 km)  awayfrom
Boston, Massachusetts
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Uludag Universitesi Tip Fakültesi

Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

Recruiting
4,854 miles (7,812 km)  awayfrom
Boston, Massachusetts
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Istanbul Üniversitesi Cerrahpaşa

Cerrahpaşa, 34098 Fatih/İstanbul, Turkey

Recruiting
4,823 miles (7,761 km)  awayfrom
Boston, Massachusetts
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Ege Universitesi Tip Fakultesi

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

Recruiting
4,863 miles (7,826 km)  awayfrom
Boston, Massachusetts
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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
5,190 miles (8,353 km)  awayfrom
Boston, Massachusetts
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19 Mayis Universitesi

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

Recruiting
5,091 miles (8,194 km)  awayfrom
Boston, Massachusetts
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MI Cherkasy Reg Onc Dis of CRC

Michigan, USA

Recruiting
742 miles (1,194 km)  awayfrom
Boston, Massachusetts
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SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

Lviv, Lviv Oblast, Ukraine, 79000

Recruiting
4,269 miles (6,871 km)  awayfrom
Boston, Massachusetts
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CI Zaporizhzhia Reg CCH of ZRC

Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

Recruiting
4,756 miles (7,653 km)  awayfrom
Boston, Massachusetts
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Royal Manchester Children's Hospital

Oxford Rd, Manchester M13 9WL, UK

Recruiting
3,148 miles (5,065 km)  awayfrom
Boston, Massachusetts
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Univ Hospital Southampton

Coxford Rd, Southampton SO16 5YA, UK

Recruiting
3,229 miles (5,197 km)  awayfrom
Boston, Massachusetts
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Bristol Royal H. for Children

Upper Maudlin St, Bristol BS2 8BJ, UK

Recruiting
3,171 miles (5,103 km)  awayfrom
Boston, Massachusetts
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Evelina Children's Hospital - St Thomas' Hospital

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

Recruiting
3,271 miles (5,265 km)  awayfrom
Boston, Massachusetts
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Medizinische Universitat Wien

Spitalgasse 23, 1090 Wien, Austria

Currently On Hold
4,032 miles (6,488 km)  awayfrom
Boston, Massachusetts
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Terminated/Withdrawn
3,890 miles (6,261 km)  awayfrom
Boston, Massachusetts
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View all (92)
Trial Protocol ID: 261203
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