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
5,846 miles (9,409 km)  awayfrom
Czech Republic
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Kaiser Permanente Oakland M.C.

10050 N Wolfe Rd, Cupertino, CA 95014, USA

Site Contact
Recruiting
5,882 miles (9,467 km)  awayfrom
Czech Republic
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Kaiser Permanente Oakland M.C.

3600 Broadway, Oakland, CA 94611, USA

Site Contact
Recruiting
5,857 miles (9,426 km)  awayfrom
Czech Republic
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Kaiser Permanente Oakland M.C.

1600 Eureka Rd, Roseville, CA 95661, USA

Site Contact
Recruiting
5,776 miles (9,295 km)  awayfrom
Czech Republic
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UC Davis Health System

2315 Stockton Blvd, Sacramento, CA 95817, USA

Recruiting
5,793 miles (9,322 km)  awayfrom
Czech Republic
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Connecticut Children's Med Ctr

282 Washington St, Hartford, CT 06106, USA

Site Contact
Recruiting
4,031 miles (6,487 km)  awayfrom
Czech Republic
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Univ Florida College Medicine

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

Recruiting
5,003 miles (8,051 km)  awayfrom
Czech Republic
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Center for Advanced Pediatrics

1400 Tullie Rd NE, Atlanta, GA 30329, USA

Recruiting
4,867 miles (7,833 km)  awayfrom
Czech Republic
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Ann & Robert H. Lurie Children's H

225 E Chicago Ave, Chicago, IL 60611, USA

Recruiting
4,582 miles (7,373 km)  awayfrom
Czech Republic
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Bleeding and Clotting Dis.Inst.

9128 N Lindbergh Dr, Peoria, IL 61615, USA

Recruiting
4,707 miles (7,576 km)  awayfrom
Czech Republic
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UMHS

2903 Baxter Rd, Ann Arbor, MI 48109, USA

Recruiting
4,421 miles (7,115 km)  awayfrom
Czech Republic
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New York Presbyterian Hospital

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

Recruiting
4,126 miles (6,639 km)  awayfrom
Czech Republic
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Novant Health Presbyterian Medical Center

200 Hawthorne Ln, Charlotte, NC 28204, USA

Recruiting
4,661 miles (7,501 km)  awayfrom
Czech Republic
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Wake Forest Baptist Medical Center

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

Recruiting
4,596 miles (7,396 km)  awayfrom
Czech Republic
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Cincinnati Children's Hospital

3333 Burnet Ave, Cincinnati, OH 45229, USA

Recruiting
4,606 miles (7,413 km)  awayfrom
Czech Republic
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Rainbow Babies/Childrens Htl

11100 Euclid Ave, Cleveland, OH 44106, USA

Recruiting
4,383 miles (7,053 km)  awayfrom
Czech Republic
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Penn State MS Hershey Med Ctr

500 University Dr, Hershey, PA 17033, USA

Recruiting
4,255 miles (6,847 km)  awayfrom
Czech Republic
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Texas Tech University Health Sciences Center

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

Recruiting
5,772 miles (9,288 km)  awayfrom
Czech Republic
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Texas Children's Hospital

6621 Fannin St, Houston, TX 77030, USA

Recruiting
5,504 miles (8,858 km)  awayfrom
Czech Republic
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Primary Children's Hospital

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

Recruiting
5,410 miles (8,707 km)  awayfrom
Czech Republic
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HUDERF

Avenue Jean Joseph Crocq 15, 1020 Bruxelles, Belgium

Recruiting
492 miles (791 km)  awayfrom
Czech Republic
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Cliniques Uni Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

Recruiting
486 miles (782 km)  awayfrom
Czech Republic
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Univ. Ziekenhuis Gent Apotheek

Zwijnaardsesteenweg 566, 9000 Gent, Belgium

Recruiting
519 miles (835 km)  awayfrom
Czech Republic
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Universitair Ziekenhuis Leuven

Herestraat 49, 3000 Leuven, Belgium

Recruiting
477 miles (767 km)  awayfrom
Czech Republic
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UMHAT Sv. Georgi, EAD

4000 Plovdiv, Bulgaria

Recruiting
692 miles (1,114 km)  awayfrom
Czech Republic
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SHAT Oncohaematology Diseases

Sofia, Bulgaria

Recruiting
618 miles (994 km)  awayfrom
Czech Republic
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MHAT Sv. Marina, EAD

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

Recruiting
748 miles (1,204 km)  awayfrom
Czech Republic
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Kaye Edmonton Clinic

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

Recruiting
4,707 miles (7,575 km)  awayfrom
Czech Republic
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McMaster Health Science

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

Recruiting
4,237 miles (6,819 km)  awayfrom
Czech Republic
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Rigshospitalet Copenhagen

Blegdamsvej 9, 2100 København, Denmark

Recruiting
427 miles (688 km)  awayfrom
Czech Republic
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Helsinki Univ Hospital

Haartmaninkatu 4 Rakennus 1, 00290 Helsinki, Finland

Recruiting
814 miles (1,309 km)  awayfrom
Czech Republic
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CHU CAEN Hopital Cote de Nacre

Avenue de la Côte de Nacre, 14000 Caen, France

Recruiting
704 miles (1,134 km)  awayfrom
Czech Republic
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Essais cliniques CHU Rennes

2 Rue Henri le Guilloux, 35000 Rennes, France

Recruiting
779 miles (1,254 km)  awayfrom
Czech Republic
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Hopital Necker Enfants Malades

149 Rue de Sèvres, 75015 Paris, France

Recruiting
589 miles (948 km)  awayfrom
Czech Republic
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Hopital Jeanne de Flandre - CHU Lille

Avenue Eugène Avinée, 59000 Lille, France

Recruiting
547 miles (881 km)  awayfrom
Czech Republic
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CHU de Rouen

37 Boulevard Gambetta, 76000 Rouen, France

Recruiting
637 miles (1,025 km)  awayfrom
Czech Republic
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Werlhof-Institut GmbH

Schillerstraße 23, 30159 Hannover, Germany

Recruiting
304 miles (489 km)  awayfrom
Czech Republic
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Inst. f. Experimentelle

Sigmund-Freud-Straße 25, 53127 Bonn, Germany

Recruiting
370 miles (595 km)  awayfrom
Czech Republic
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Klinik F.Haematologie,Onkologie

Moorenstraße 5, 40225 Düsseldorf, Germany

Recruiting
389 miles (626 km)  awayfrom
Czech Republic
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Poliklinik PaediaHaematologie

Hamburg, Germany

Recruiting
349 miles (561 km)  awayfrom
Czech Republic
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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
5,430 miles (8,739 km)  awayfrom
Czech Republic
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Chinese University Of Hong Kong

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

Recruiting
5,425 miles (8,731 km)  awayfrom
Czech Republic
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Belgyogyaszat Onkohaematologia

Budapest, Hungary

Recruiting
229 miles (369 km)  awayfrom
Czech Republic
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Debreceni Egyetem

Debrecen, Egyetem tér 1, 4032 Hungary

Recruiting
324 miles (522 km)  awayfrom
Czech Republic
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Presidio Ospedaliero F. Alessi

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

Recruiting
845 miles (1,360 km)  awayfrom
Czech Republic
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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

Recruiting
453 miles (730 km)  awayfrom
Czech Republic
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Ospedale Maggiore Policlinico

Via Francesco Sforza, 35, 20122 Milano MI, Italy

Recruiting
411 miles (662 km)  awayfrom
Czech Republic
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Umberto I Pol. di Roma-Università di Roma La Sapienza

Piazzale Aldo Moro, 5, 00185 Roma RM, Italy

Recruiting
558 miles (898 km)  awayfrom
Czech Republic
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Eulji University Hospital

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

Recruiting
5,189 miles (8,351 km)  awayfrom
Czech Republic
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Severance Hospital, Yonsei

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

Recruiting
5,109 miles (8,221 km)  awayfrom
Czech Republic
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Kyung Hee University Hospital

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

Recruiting
5,116 miles (8,234 km)  awayfrom
Czech Republic
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Ulsan University Hospital

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

Recruiting
5,305 miles (8,537 km)  awayfrom
Czech Republic
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Hospital Ampang

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

Recruiting
5,894 miles (9,485 km)  awayfrom
Czech Republic
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Hospital HRPB

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

Recruiting
5,786 miles (9,312 km)  awayfrom
Czech Republic
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Hospital Pulau Pinang

Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia

Recruiting
5,708 miles (9,187 km)  awayfrom
Czech Republic
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Hospital Kuala Lumpur

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

Recruiting
5,889 miles (9,477 km)  awayfrom
Czech Republic
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Hospital Umum Sarawak

Jalan Hospital, 93586 Kuching, Sarawak, Malaysia

Recruiting
6,360 miles (10,235 km)  awayfrom
Czech Republic
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Hospital Sultanah Nur Zahirah

20400 Kuala Terengganu, Terengganu, Malaysia

Recruiting
5,840 miles (9,398 km)  awayfrom
Czech Republic
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Universitair Medisch Centrum Groningen (UMCG)

Hanzeplein 1, 9713 GZ Groningen, Netherlands

Recruiting
447 miles (719 km)  awayfrom
Czech Republic
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Oslo Universitetssykehus - Rikshospitalet

Sognsvannsveien 20, 0372 Oslo, Norway

Recruiting
728 miles (1,172 km)  awayfrom
Czech Republic
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NUS YLL School of Medicine

10 Medical Dr, Singapore 117597

Recruiting
6,080 miles (9,785 km)  awayfrom
Czech Republic
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KKH

100 Bukit Timah Rd, Singapore 229899

Recruiting
6,082 miles (9,789 km)  awayfrom
Czech Republic
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Hospital Univ. Son Espases

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

Site Contact
Recruiting
935 miles (1,505 km)  awayfrom
Czech Republic
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HOSPITAL A Coruna

Xubias de Arriba, 84, 15006 A Coruña, Spain

Recruiting
1,205 miles (1,939 km)  awayfrom
Czech Republic
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Hospital Universitario La Paz

Paseo de la Castellana, 261, 28046 Madrid, Spain

Recruiting
1,122 miles (1,805 km)  awayfrom
Czech Republic
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Hospital Univ del Rio Hortega

Calle Dulzaina, 2, 47012 Valladolid, Spain

Recruiting
1,113 miles (1,792 km)  awayfrom
Czech Republic
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Kaohsiung Chung- Ho Memorial Hosp

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

Recruiting
5,663 miles (9,114 km)  awayfrom
Czech Republic
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China Medical University Hospital

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

Recruiting
5,597 miles (9,007 km)  awayfrom
Czech Republic
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Taichung Veterans General

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

Recruiting
5,592 miles (9,000 km)  awayfrom
Czech Republic
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Tri-Service General Hospital

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

Recruiting
5,584 miles (8,986 km)  awayfrom
Czech Republic
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Siriraj Hospital

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

Recruiting
5,281 miles (8,498 km)  awayfrom
Czech Republic
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King Chulalongkorn Memorial

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

Recruiting
5,284 miles (8,504 km)  awayfrom
Czech Republic
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Ramathibodi Hospital

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

Recruiting
5,282 miles (8,501 km)  awayfrom
Czech Republic
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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
4,955 miles (7,975 km)  awayfrom
Czech Republic
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Srinagarind Hospital

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

Recruiting
5,245 miles (8,440 km)  awayfrom
Czech Republic
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Acibadem Adana Hospital

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

Recruiting
1,327 miles (2,136 km)  awayfrom
Czech Republic
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Hacettepe Üniversitesi

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

Recruiting
1,089 miles (1,753 km)  awayfrom
Czech Republic
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Akdeniz Universitesi

Akdeniz Ünv., Konyaaltı/Antalya, Turkey

Recruiting
1,170 miles (1,883 km)  awayfrom
Czech Republic
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Uludag Universitesi Tip Fakültesi

Görükle Kampüsü, Özlüce, 16059 Nilüfer/Bursa, Turkey

Recruiting
930 miles (1,497 km)  awayfrom
Czech Republic
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Istanbul Üniversitesi Cerrahpaşa

Cerrahpaşa, 34098 Fatih/İstanbul, Turkey

Recruiting
892 miles (1,436 km)  awayfrom
Czech Republic
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Ege Universitesi Tip Fakultesi

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

Recruiting
975 miles (1,569 km)  awayfrom
Czech Republic
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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
1,251 miles (2,013 km)  awayfrom
Czech Republic
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19 Mayis Universitesi

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

Recruiting
1,158 miles (1,863 km)  awayfrom
Czech Republic
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MI Cherkasy Reg Onc Dis of CRC

Michigan, USA

Recruiting
4,391 miles (7,066 km)  awayfrom
Czech Republic
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SI Institute of Blood Pathology and Transfusion Medicine of NAMSU

Lviv, Lviv Oblast, Ukraine, 79000

Recruiting
388 miles (624 km)  awayfrom
Czech Republic
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CI Zaporizhzhia Reg CCH of ZRC

Zaporizhzhia, Zaporizhia Oblast, Ukraine, 69061

Recruiting
908 miles (1,461 km)  awayfrom
Czech Republic
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Royal Manchester Children's Hospital

Oxford Rd, Manchester M13 9WL, UK

Recruiting
794 miles (1,278 km)  awayfrom
Czech Republic
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Univ Hospital Southampton

Coxford Rd, Southampton SO16 5YA, UK

Recruiting
743 miles (1,195 km)  awayfrom
Czech Republic
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Bristol Royal H. for Children

Upper Maudlin St, Bristol BS2 8BJ, UK

Recruiting
793 miles (1,277 km)  awayfrom
Czech Republic
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Evelina Children's Hospital - St Thomas' Hospital

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

Recruiting
687 miles (1,106 km)  awayfrom
Czech Republic
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Medizinische Universitat Wien

Spitalgasse 23, 1090 Wien, Austria

Currently On Hold
115 miles (185 km)  awayfrom
Czech Republic
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Terminated/Withdrawn
50 miles (80 km)  awayfrom
Czech Republic
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View all (92)
Trial Protocol ID: 261203
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