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Efficacy and Safety Study of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

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

The purpose of this study is to compare the efficacy of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant (HSCT) recipients.

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?   No
How many participants are being enrolled?   550
When is the trial being conducted?    - 
How long is participation in the trial?   Planned duration of screening phase: 2 weeks, planned duration of treatment phase: 8 weeks, planned duration of follow-up phase: 12 weeks. All patients who meet the eligibility requirements during the screening phase will be randomly selected to receive either maribavir or valganciclovir during the 8 week treatment phase. This study requires approximately 18 visits to the study site.

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, 16 and 20 Regardless of Whether Study Assigned Treatment was Completed [Time Frame: Week 8 through Weeks 12, 16 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: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir [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 [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 [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 [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 [Time Frame: Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1]
Entry Criteria:
Recipient of hematopoietic stem cell transplant Have a documented asymptomatic CMV infection If presenting with recurrent CMV infection, have at least 2 weeks of undetectable CMV DNA Must not have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir Must not require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated Must not be receiving leflunomide, or artesunate when study treatment is initiated Must not be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or cidofovir) for the current CMV infection for longer than 72 hours.

Trial Locations

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RESULTS
UCLA Medical Center

757 Westwood Plaza, Los Angeles, CA 90095, USA

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Stanford University

450 Serra Mall, Stanford, CA 94305, USA

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Yale University School of Medicine

333 Cedar St, New Haven, CT 06510, USA

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Emory University

201 Dowman Dr, Atlanta, GA 30322, USA

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Loyola University Medical Center

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

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University of Maryland School of Medicine

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

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Johns Hopkins Hospital

1800 Orleans St, Baltimore, MD 21287, USA

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Beth Israel Deaconess Medical Center

330 Brookline Ave, Boston, MA 02215, USA

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Brigham and Womens Hospital

75 Francis St, Boston, MA 02115, USA

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UMass Memorial Medical Center

55 N Lake Ave, Worcester, MA 01655, USA

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Henry Ford Health System

1 Ford Pl, Detroit, MI 48202, USA

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University of Minnesota

Minneapolis, MN 55455, USA

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Hackensack University Medical Center

30 Prospect Ave, Hackensack, NJ 07601, USA

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Joan and sandford I. Weill Medical College of Cornell University Clinic

1300 York Ave, New York, NY 10065, USA

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Memorial Sloan Kettering Cancer Center

1275 York Ave, New York, NY 10065, USA

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University of Pennsylvania

Philadelphia, PA 19104, USA

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VA Puget Sound Health Care System - NAVREF

1660 S Columbian Way, Seattle, WA 98108, USA

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The Medical College of Wisconsin, Inc.

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

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Royal Adelaide Hospital

Port Rd, Adelaide SA 5000, Australia

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Royal Melbourne Hospital

Royal Melbourne Hospital, Parkville VIC 3050, Australia

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UZ Antwerpen

Drie Eikenstraat 655, 2650 Edegem, Belgium

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Institute Jules Bordet

Boulevard de Waterloo 121, 1000 Bruxelles, Belgium

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Cliniques Universitaires Saint-Luc

Avenue Hippocrate 10, 1200 Bruxelles, Belgium

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University Hospital Gent

Corneel Heymanslaan 10, 9000 Gent, Belgium

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UZ Leuven

Herestraat 49, 3000 Leuven, Belgium

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AZ Sint-Jan AV

Ruddershove 10, 8000 Brugge, Belgium

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CHU de Liège

Avenue de L'Hôpital 1, 4000 Liège, Belgium

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Vancouver General Hospital

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

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Hamilton Health Sciences Corporation

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

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University Hospital Center Zagreb

Kišpatićeva ul. 12, 10000, Zagreb, Croatia

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Fakultni nemocnice v Motole

V Úvalu 84, 150 06 Praha 5, Czechia

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Ustav hematologie a krevni transfuze

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

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CHU de Bordeaux

Avenue du Haut Lévêque, 33604 Pessac, France

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CHU de GRENOBLE

Avenue Maquis du Grésivaudan, 38700 La Tronche, France

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Hôtel Dieu

1 Place Alexis-Ricordeau, 44000 Nantes, France

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CHU Angers

4 Rue Larrey, 49100 Angers, France

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Hopital Henri Mondor

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

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Hopital Jean Minjoz

3 Boulevard Alexandre Fleming, 25000 Besançon, France

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Hôpital Universitaire Dupuytren

2 Avenue Martin Luther King, 87000 Limoges, France

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Hôpital Saint Louis

1 Avenue Claude Vellefaux, 75010 Paris, France

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EDOG - Institut Claudius Regaud - PPDS

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

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Universität des Saarlandes

Kirrberger Str. 100, 66421 Homburg, Germany

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Universitatsklinikum Leipzig

Liebigstraße 20, 04103 Leipzig, Germany

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Universitätsklinikum Augsburg

Stenglinstraße 2, 86156 Augsburg, Germany

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Helios Klinikum Berlin-Buch

Schwanebecker Chaussee 50, 13125 Berlin, Germany

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Martin Luther Universitat Halle Wittenberg

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

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Universitätsklinikum Hamburg Eppendorf

Martinistraße 52, 20251 Hamburg, Germany

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Universitätsklinik Rostock

Schillingallee 35, 18057 Rostock, Germany

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Robert Bosch Krankenhaus

Robert-Bosch-Krankenhaus, 70376 Stuttgart, Germany

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Universitätsklinikum Tübingen

Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany

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Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

Budapest, Nagyvárad tér 1, 1097 Hungary

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Ospedale Infantile Regina Margherita

Piazza Polonia, 94, 10126 Torino TO, Italy

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Azienda Ospedaliera Universitaria Integrata Di Verona

Piazzale Aristide Stefani, 1, 37126 Verona VR, Italy

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Azienda Ospedaliera Universitaria Careggi

Largo Piero Palagi, 1, 50139 Firenze FI, Italy

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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Via della Commenda, 10, 20122 Milano MI, Italy

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Fondazione Policlinico Universitario A Gemelli

Via Giuseppe Moscati, 31, 00168 Roma RM, Italy

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Azienda Ospedaliera Città della Salute e della Scienza di Torino

Corso Bramante, 88, 10126 Torino TO, Italy

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Dong-A University Hospital

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

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Keimyung University Dongsan Hospital

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

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Auckland City Hospital

2 Park Road, Grafton, Auckland 1023, New Zealand

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Canterbury Health Laboratories

Hagley Avenue, Addington, Christchurch 8011, New Zealand

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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Borowska 213, 50-556 Wrocław, Poland

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MTZ Clinical Research Sp z o o

Adolfa Pawińskiego 5, 02-106 Warszawa, Poland

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Uniwersyteckie Centrum Kliniczne - PPDS

Mariana Smoluchowskiego 17, 80-214 Gdańsk, Poland

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National University Hospital

5 Lower Kent Ridge Rd, Singapore 119074

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Singapore General Hospital (SGH)

Outram Rd, Singapore 169608

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Hospital Universitario Germans Trias i Pujol

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

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Hospital Universitario Marques de Valdecilla

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

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Complejo Asistencial Universitario de Salamanca - H. Clinico

Paseo de San Vicente, 58, 37007 Salamanca, Spain

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Hospital Universitario Vall d'Hebrón - PPDS

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

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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

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C.H. Regional Reina Sofia - PPDS

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

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Hospital Universitario Virgen de Las Nieves

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

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Hospital Universitario de La Princesa

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

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Hospital Universitario Ramon y Cajal

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

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Hospital Universitario Puerta de Hierro - Majadahonda

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

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Hospital Regional Universitario de Malaga - Hospital General

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

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Hospital Universitario de Donostia

20014 San Sebastián-Donostia, Guipúzcoa, Spain

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Hospital Clinico Universitario de Valencia

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

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Hospital Universitari i Politecnic La Fe de Valencia

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

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Universitätsspital Zürich

Rämistrasse 100, 8091 Zürich, Switzerland

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Baskent University Medical Faculty Adana Practice and Research Center

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

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Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS

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

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Birmingham Heartlands Hospital

Bordesley Green E, Birmingham B9 5SS, UK

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Hammersmith Hospital

72 Du Cane Rd, London W12 0HS, UK

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University College London

Gower St, Bloomsbury, London WC1E 6BT, UK

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St George's Hospital

Blackshaw Rd, Tooting, London SW17 0QT, UK

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Royal Liverpool University Hospital

Prescot St, Liverpool L7 8XP, UK

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The Christie NHS Foundation Trust - PPDS

Wilmslow Rd, Manchester M20 4BX, UK

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Southampton University Hospitals NHS Trust

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

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University of Alabama at Birmingham

Birmingham, AL 35294, USA

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Colorado Blood Cancer Institute

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

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University of Chicago

5801 S Ellis Ave, Chicago, IL 60637, USA

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Mayo Clinic - PPDS

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

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Columbia University Medical Center

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

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TriStar Centennial Medical Center

2300 Patterson St, Nashville, TN 37203, USA

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Saint Davids South Austin Medical Center

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

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University of Texas MD Anderson Cancer Center

1515 Holcombe Blvd, Houston, TX 77030, USA

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Texas Transplant Institute

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

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Westmead Hospital

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

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Queen Elizabeth II Health Sciences Center

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

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Hopital de Hautepierre

1 Avenue Molière, 67200 Strasbourg, France

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Institut Paoli Calmettes

232 Boulevard de Sainte-Marguerite, 13009 Marseille, France

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Universitätsklinikum Münster

Albert-Schweitzer-Campus 1, 48149 Münster, Germany

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Ospedale Dell'Angelo

Via Paccagnella, 11, 30174 Venezia VE, Italy

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Trial Protocol ID: SHP620-302
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