A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

IDENTIFIERS
Trial Protocol: SHP620-302
Clinicaltrials.gov: NCT02927067
EudraCT: 2015-004726-34
PURPOSE

This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.

Recruiting
US
AU
BE
15+
CA
HR
CZ
FR
DE
HU
IT
KR
NZ
PL
SG
ES
CH
TR
GB

Trial at a glance

What medical condition is being studied?   Cytomegalovirus (CMV)
What is the trial testing?   Maribavir, Valganciclovir, Placebo
Are placebos part of the trial?   Yes
How many participants are being enrolled?   550
When is the trial being conducted?    - 
How long is participation in the trial?   Each participant will be in the study for up to 22 weeks. This includes screening for the study.

Key requirements

Sex   
All
Age   
From 16 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:   
Maribavir/ Placebo: Participants will receive 400 milligrams (mg) of maribavir (2*200 mg tablets) twice daily (BID) orally along with a placebo matched to valganciclovir for 8 weeks.
Valganciclovir/ Placebo: Participants will receive 900 mg of valganciclovir (2*450 mg tablets) BID orally along with a placebo matched to maribavir for 8 weeks. Valganciclovir dose may be adjusted to 450 mg BID or 450 mg QD during the study for renal function impairment or neutropenia.
Intervention:   Maribavir, Valganciclovir, Placebo
Primary Outcome Measure(s):
Proportion of Participants With Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at the End of Study Week 8, Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8]
Secondary Outcome Measure(s):   
Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance Achieved at the End of Study Week 8 Through Study Week 16, Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8 through Week 16]
Proportion of Participants Who Achieve Confirmed CMV Viremia Clearance After 8 Weeks of Receiving Study-assigned Treatment [Time Frame: Week 8]
Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12, 16 and 20 [Time Frame: Week 8 through Weeks 12, 16 and 20]
Proportion of Participants Who Maintained Confirmed CMV Viremia Clearance After Completion of 8 Weeks of Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8 through Weeks 12 and 20]
Proportion of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment [Time Frame: Baseline up to Week 20]
Incidence of Grade 3 or 4 Neutropenia [Time Frame: Baseline up to Week 8]
Number of Participants With Treatment-Emergent Adverse Events [Time Frame: Baseline up to Week 20]
Predose Concentration (Cmin) of Maribavir [Time Frame: Weeks 1, 4, and 8: pre-morning dose]
Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Entry Criteria:
- Boys, girls, men, and women can take part. - Must 16 years or older. - Must be a recipient of hematopoietic stem cell transplant. - Must have a documented asymptomatic CMV infection. Additional entry criteria will be discussed with the study doctor.

Trial Locations

Any
Completed
Recruiting
Any
RESULTS
UCLA Medical Center

757 Westwood Plaza, Los Angeles, CA 90095, USA

Recruiting
5,992 miles (9,643 km)  awayfrom
Czech Republic
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Stanford University

450 Serra Mall, Stanford, CA 94305, USA

Recruiting
5,880 miles (9,462 km)  awayfrom
Czech Republic
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Yale University School of Medicine

333 Cedar St, New Haven, CT 06510, USA

Recruiting
4,061 miles (6,536 km)  awayfrom
Czech Republic
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Emory University

201 Dowman Dr, Atlanta, GA 30322, USA

Recruiting
4,868 miles (7,835 km)  awayfrom
Czech Republic
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Loyola University Medical Center

2160 S 1st Ave, Maywood, IL 60153, USA

Recruiting
4,591 miles (7,388 km)  awayfrom
Czech Republic
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University of Maryland School of Medicine

655 W Baltimore St S, Baltimore, MD 21201, USA

Recruiting
4,299 miles (6,918 km)  awayfrom
Czech Republic
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Johns Hopkins Hospital

1800 Orleans St, Baltimore, MD 21287, USA

Recruiting
4,297 miles (6,915 km)  awayfrom
Czech Republic
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Beth Israel Deaconess Medical Center

330 Brookline Ave, Boston, MA 02215, USA

Recruiting
3,943 miles (6,345 km)  awayfrom
Czech Republic
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Brigham and Womens Hospital

75 Francis St, Boston, MA 02115, USA

Recruiting
3,943 miles (6,346 km)  awayfrom
Czech Republic
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UMass Memorial Medical Center

55 N Lake Ave, Worcester, MA 01655, USA

Recruiting
3,971 miles (6,391 km)  awayfrom
Czech Republic
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Henry Ford Health System

1 Ford Pl, Detroit, MI 48202, USA

Recruiting
4,395 miles (7,074 km)  awayfrom
Czech Republic
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University of Minnesota

Minneapolis, MN 55455, USA

Recruiting
4,616 miles (7,428 km)  awayfrom
Czech Republic
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Hackensack University Medical Center

30 Prospect Ave, Hackensack, NJ 07601, USA

Recruiting
4,124 miles (6,637 km)  awayfrom
Czech Republic
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Joan and sandford I. Weill Medical College of Cornell University Clinic

1300 York Ave, New York, NY 10065, USA

Recruiting
4,126 miles (6,639 km)  awayfrom
Czech Republic
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Memorial Sloan Kettering Cancer Center

1275 York Ave, New York, NY 10065, USA

Recruiting
4,126 miles (6,640 km)  awayfrom
Czech Republic
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University of Pennsylvania

Philadelphia, PA 19104, USA

Recruiting
4,212 miles (6,778 km)  awayfrom
Czech Republic
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VA Puget Sound Health Care System - NAVREF

1660 S Columbian Way, Seattle, WA 98108, USA

Recruiting
5,255 miles (8,457 km)  awayfrom
Czech Republic
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The Medical College of Wisconsin, Inc.

8701 W Watertown Plank Rd, Wauwatosa, WI 53226, USA

Recruiting
4,538 miles (7,303 km)  awayfrom
Czech Republic
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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

Recruiting
9,442 miles (15,196 km)  awayfrom
Czech Republic
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Royal Melbourne Hospital

Royal Melbourne Hospital, Parkville VIC 3050, Australia

Recruiting
9,845 miles (15,844 km)  awayfrom
Czech Republic
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UZ Antwerpen

Drie Eikenstraat 655, 2650 Edegem, Belgium

Recruiting
490 miles (789 km)  awayfrom
Czech Republic
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Institute Jules Bordet

Boulevard de Waterloo 121, 1000 Bruxelles, Belgium

Recruiting
491 miles (789 km)  awayfrom
Czech Republic
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Cliniques Universitaires Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

Recruiting
486 miles (782 km)  awayfrom
Czech Republic
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University Hospital Gent

Corneel Heymanslaan 10, 9000 Gent, Belgium

Recruiting
519 miles (835 km)  awayfrom
Czech Republic
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UZ Leuven

Herestraat 49, 3000 Leuven, Belgium

Recruiting
477 miles (767 km)  awayfrom
Czech Republic
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AZ Sint-Jan AV

Ruddershove 10, 8000 Brugge, Belgium

Recruiting
543 miles (874 km)  awayfrom
Czech Republic
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CHU de Liège

Avenue de L'Hôpital 1, 4000 Liège, Belgium

Recruiting
436 miles (702 km)  awayfrom
Czech Republic
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Vancouver General Hospital

899 W 12th Ave, Vancouver, BC V5Z 1M9, Canada

Recruiting
5,166 miles (8,314 km)  awayfrom
Czech Republic
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Hamilton Health Sciences Corporation

100 King St W, Hamilton, ON L8N 3Z5, Canada

Recruiting
4,235 miles (6,816 km)  awayfrom
Czech Republic
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University Hospital Center Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

Recruiting
272 miles (438 km)  awayfrom
Czech Republic
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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

Recruiting
50 miles (80 km)  awayfrom
Czech Republic
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Ustav hematologie a krevni transfuze

1, U Nemocnice 2094, 128 20 Nové Město, Czechia

Recruiting
47 miles (75 km)  awayfrom
Czech Republic
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CHU de Bordeaux

Avenue du Haut Lévêque, 33604 Pessac, France

Recruiting
822 miles (1,323 km)  awayfrom
Czech Republic
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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

Recruiting
546 miles (879 km)  awayfrom
Czech Republic
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Hôtel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

Recruiting
791 miles (1,274 km)  awayfrom
Czech Republic
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CHU Angers

4 Rue Larrey, 49100 Angers, France

Recruiting
741 miles (1,193 km)  awayfrom
Czech Republic
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Hopital Henri Mondor

51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France

Recruiting
584 miles (940 km)  awayfrom
Czech Republic
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Hopital Jean Minjoz

3 Boulevard Alexandre Fleming, 25000 Besançon, France

Recruiting
463 miles (745 km)  awayfrom
Czech Republic
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Hôpital Universitaire Dupuytren

2 Avenue Martin Luther King, 87000 Limoges, France

Recruiting
707 miles (1,139 km)  awayfrom
Czech Republic
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Hôpital Saint Louis

1 Avenue Claude Vellefaux, 75010 Paris, France

Recruiting
587 miles (944 km)  awayfrom
Czech Republic
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EDOG - Institut Claudius Regaud - PPDS

1 Av. Irène Joliot-Curie, 31100 Toulouse, France

Recruiting
784 miles (1,262 km)  awayfrom
Czech Republic
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Universität des Saarlandes

Kirrberger Str. 100, 66421 Homburg, Germany

Recruiting
360 miles (579 km)  awayfrom
Czech Republic
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Universitatsklinikum Leipzig

Liebigstraße 20, 04103 Leipzig, Germany

Recruiting
170 miles (273 km)  awayfrom
Czech Republic
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Universitätsklinikum Augsburg

Stenglinstraße 2, 86156 Augsburg, Germany

Recruiting
224 miles (361 km)  awayfrom
Czech Republic
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Helios Klinikum Berlin-Buch

Schwanebecker Chaussee 50, 13125 Berlin, Germany

Recruiting
215 miles (346 km)  awayfrom
Czech Republic
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Martin Luther Universitat Halle Wittenberg

Von-Danckelmann-Platz 3, 06120 Halle (Saale), Germany

Recruiting
192 miles (309 km)  awayfrom
Czech Republic
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Universitätsklinikum Hamburg Eppendorf

Martinistraße 52, 20251 Hamburg, Germany

Recruiting
351 miles (565 km)  awayfrom
Czech Republic
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Universitätsklinik Rostock

Schillingallee 35, 18057 Rostock, Germany

Recruiting
330 miles (531 km)  awayfrom
Czech Republic
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Robert Bosch Krankenhaus

Robert-Bosch-Krankenhaus, 70376 Stuttgart, Germany

Recruiting
285 miles (458 km)  awayfrom
Czech Republic
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Universitätsklinikum Tübingen

Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany

Recruiting
297 miles (478 km)  awayfrom
Czech Republic
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Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Budapest, Nagyvárad tér 1, 1097 Hungary

Recruiting
232 miles (373 km)  awayfrom
Czech Republic
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Ospedale Infantile Regina Margherita

Piazza Polonia, 94, 10126 Torino TO, Italy

Recruiting
484 miles (778 km)  awayfrom
Czech Republic
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Azienda Ospedaliera Universitaria Integrata Di Verona

Piazzale Aristide Stefani, 1, 37126 Verona VR, Italy

Recruiting
359 miles (578 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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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

Recruiting
411 miles (662 km)  awayfrom
Czech Republic
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Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

Recruiting
558 miles (898 km)  awayfrom
Czech Republic
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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

Recruiting
483 miles (778 km)  awayfrom
Czech Republic
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Dong-A University Hospital

26 Daesingongwon-ro, Dongdaesin 3(sam)-dong, Seo-gu, Busan, South Korea

Recruiting
5,313 miles (8,550 km)  awayfrom
Czech Republic
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Keimyung University Dongsan Hospital

1035 Dalgubeol-daero, Sindang-dong, Dalseo-gu, Daegu, South Korea

Recruiting
5,254 miles (8,456 km)  awayfrom
Czech Republic
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Auckland City Hospital

2 Park Road, Grafton, Auckland 1023, New Zealand

Recruiting
11,080 miles (17,831 km)  awayfrom
Czech Republic
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Canterbury Health Laboratories

Hagley Avenue, Addington, Christchurch 8011, New Zealand

Recruiting
11,282 miles (18,157 km)  awayfrom
Czech Republic
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Borowska 213, 50-556 Wrocław, Poland

Recruiting
118 miles (191 km)  awayfrom
Czech Republic
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MTZ Clinical Research Sp z o o

Adolfa Pawińskiego 5, 02-106 Warszawa, Poland

Recruiting
299 miles (481 km)  awayfrom
Czech Republic
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Uniwersyteckie Centrum Kliniczne - PPDS

Mariana Smoluchowskiego 17, 80-214 Gdańsk, Poland

Recruiting
348 miles (561 km)  awayfrom
Czech Republic
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National University Hospital

5 Lower Kent Ridge Rd, Singapore 119074

Recruiting
6,080 miles (9,785 km)  awayfrom
Czech Republic
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Singapore General Hospital (SGH)

Outram Rd, Singapore 169608

Recruiting
6,084 miles (9,791 km)  awayfrom
Czech Republic
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Hospital Universitario Germans Trias i Pujol

Carretera de Canyet, s/n, 08916 Badalona, Barcelona, Spain

Recruiting
850 miles (1,368 km)  awayfrom
Czech Republic
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Hospital Universitario Marques de Valdecilla

Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain

Recruiting
1,004 miles (1,616 km)  awayfrom
Czech Republic
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Complejo Asistencial Universitario de Salamanca - H. Clinico

Paseo de San Vicente, 58, 37007 Salamanca, Spain

Recruiting
1,181 miles (1,900 km)  awayfrom
Czech Republic
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Hospital Universitario Vall d'Hebrón - PPDS

Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain

Recruiting
856 miles (1,378 km)  awayfrom
Czech Republic
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ICO l'Hospitalet - Hospital Duran i Reynals

Avinguda de la Granvia de l’Hospitalet, 199, 08908 L'Hospitalet de Llobregat, Barcelona, Spain

Recruiting
862 miles (1,387 km)  awayfrom
Czech Republic
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C.H. Regional Reina Sofia - PPDS

Av. Menendez Pidal, s/n, 14004 Córdoba, Spain

Recruiting
1,289 miles (2,075 km)  awayfrom
Czech Republic
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Hospital Universitario Virgen de Las Nieves

Av. de las Fuerzas Armadas, 2, 18014 Granada, Spain

Recruiting
1,280 miles (2,060 km)  awayfrom
Czech Republic
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Hospital Universitario de La Princesa

Calle de Diego de León, 62, 28006 Madrid, Spain

Recruiting
1,124 miles (1,808 km)  awayfrom
Czech Republic
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Hospital Universitario Ramon y Cajal

M-607, km. 9, 100, 28034 Madrid, Spain

Recruiting
1,122 miles (1,805 km)  awayfrom
Czech Republic
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Hospital Universitario Puerta de Hierro - Majadahonda

Calle Joaquín Rodrigo, 1, 28222 Majadahonda, Madrid, Spain

Recruiting
1,131 miles (1,820 km)  awayfrom
Czech Republic
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Hospital Regional Universitario de Malaga - Hospital General

Av. de Carlos Haya, 84, 29010 Málaga, Spain

Recruiting
1,335 miles (2,148 km)  awayfrom
Czech Republic
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Hospital Universitario de Donostia

20014 San Sebastián-Donostia, Guipúzcoa, Spain

Recruiting
933 miles (1,501 km)  awayfrom
Czech Republic
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Hospital Clinico Universitario de Valencia

Av. de Blasco Ibáñez, 17, 46010 València, Valencia, Spain

Recruiting
1,045 miles (1,681 km)  awayfrom
Czech Republic
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Hospital Universitari i Politecnic La Fe de Valencia

Avinguda de Fernando Abril Martorell, 106, 46026 València, Valencia, Spain

Recruiting
1,047 miles (1,685 km)  awayfrom
Czech Republic
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Universitätsspital Zürich

Rämistrasse 100, 8091 Zürich, Switzerland

Recruiting
351 miles (564 km)  awayfrom
Czech Republic
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Baskent University Medical Faculty Adana Practice and Research Center

Bağlıca Kampüsü, Dumlupınar Blv. 20. Km, 06810 Etimesgut/Ankara, Turkey

Recruiting
1,084 miles (1,744 km)  awayfrom
Czech Republic
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Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

Emniyet, Dögol Cd. 6A, 06560 Yenimahalle/Ankara, Turkey

Recruiting
1,088 miles (1,751 km)  awayfrom
Czech Republic
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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

Recruiting
766 miles (1,233 km)  awayfrom
Czech Republic
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Hammersmith Hospital

72 Du Cane Rd, London W12 0HS, UK

Recruiting
692 miles (1,114 km)  awayfrom
Czech Republic
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University College London

Gower St, Bloomsbury, London WC1E 6BT, UK

Recruiting
688 miles (1,107 km)  awayfrom
Czech Republic
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St George's Hospital

Blackshaw Rd, Tooting, London SW17 0QT, UK

Recruiting
689 miles (1,109 km)  awayfrom
Czech Republic
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Royal Liverpool University Hospital

Prescot St, Liverpool L7 8XP, UK

Recruiting
823 miles (1,324 km)  awayfrom
Czech Republic
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The Christie NHS Foundation Trust - PPDS

Wilmslow Rd, Manchester M20 4BX, UK

Recruiting
794 miles (1,277 km)  awayfrom
Czech Republic
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Southampton University Hospitals NHS Trust

Southampton General Hospital, Tremona Rd, Southampton SO16 6YD, UK

Recruiting
743 miles (1,195 km)  awayfrom
Czech Republic
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University of Alabama at Birmingham

Birmingham, AL 35294, USA

Completed
4,979 miles (8,013 km)  awayfrom
Czech Republic
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Colorado Blood Cancer Institute

1721 E 19th Ave ste 200-300, Denver, CO 80218, USA

Completed
5,270 miles (8,481 km)  awayfrom
Czech Republic
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University of Chicago

5801 S Ellis Ave, Chicago, IL 60637, USA

Completed
4,586 miles (7,381 km)  awayfrom
Czech Republic
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Mayo Clinic - PPDS

200 1st St SW, Rochester, MN 55905, USA

Completed
4,640 miles (7,467 km)  awayfrom
Czech Republic
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Columbia University Medical Center

630 W 168th St, New York, NY 10032, USA

Completed
4,122 miles (6,633 km)  awayfrom
Czech Republic
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TriStar Centennial Medical Center

2300 Patterson St, Nashville, TN 37203, USA

Completed
4,843 miles (7,794 km)  awayfrom
Czech Republic
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Saint Davids South Austin Medical Center

901 W Ben White Blvd, Austin, TX 78704, USA

Completed
5,562 miles (8,951 km)  awayfrom
Czech Republic
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University of Texas MD Anderson Cancer Center

1515 Holcombe Blvd, Houston, TX 77030, USA

Completed
5,504 miles (8,858 km)  awayfrom
Czech Republic
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Texas Transplant Institute

8201 Ewing Halsell Dr, San Antonio, TX 78229, USA

Completed
5,630 miles (9,061 km)  awayfrom
Czech Republic
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Westmead Hospital

Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145, Australia

Completed
9,946 miles (16,006 km)  awayfrom
Czech Republic
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Queen Elizabeth II Health Sciences Center

1276 South Park St, Halifax, NS B3H 2Y9, Canada

Completed
3,548 miles (5,709 km)  awayfrom
Czech Republic
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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

Completed
354 miles (569 km)  awayfrom
Czech Republic
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Institut Paoli Calmettes

232 Boulevard de Sainte-Marguerite, 13009 Marseille, France

Completed
650 miles (1,045 km)  awayfrom
Czech Republic
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Universitätsklinikum Münster

Albert-Schweitzer-Campus 1, 48149 Münster, Germany

Completed
371 miles (596 km)  awayfrom
Czech Republic
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Ospedale Dell'Angelo

Via Paccagnella, 11, 30174 Venezia VE, Italy

Completed
326 miles (525 km)  awayfrom
Czech Republic
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View all (105)
Trial Protocol ID: SHP620-302
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