Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

PHASE3CompletedINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

December 22, 2016

Primary Completion Date

August 17, 2020

Study Completion Date

August 17, 2020

Conditions
Cytomegalovirus (CMV)
Interventions
DRUG

Maribavir

Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.

DRUG

Ganciclovir

Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

DRUG

Valganciclovir

Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

DRUG

Foscarnet

Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

DRUG

Cidofovir

Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Trial Locations (134)

1000

Institut Jules Bordet, Brussels

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1070

Hôpital Erasme, Brussels

1090

Allgemeines Krankenhaus der Stadt Wien, Vienna

UZ Brussel, Brussels

2060

ZNA Stuivenberg, Antwerp

2100

Copenhagen University Hospital, København Ø

2145

Westmead Hospital, Westmead

2650

UZ Antwerpen, Edegem

3000

UZ Leuven, Leuven

3004

The Alfred Hospital, Melbourne

3050

Royal Melbourne Hospital, Parkville

3168

Monash Health, Monash Medical Centre, Clayton

4102

Princess Alexandra Hospital, Brisbane

6009

Sir Charles Gairdner Hospital, Nedlands

6020

Tiroler Landeskrankenanstalten GmbH, Innsbruck

8000

AZ Sint-Jan AV, Bruges

9000

UZ Gent, Ghent

10000

University Hospital Center Zagreb, Zagreb

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

New York Presbyterian Hospital - Weill-Cornell, New York

12345

Azienda Sanitaria Universitaria Integrata di Udine, Udine

13210

SUNY Upstate Medical Center, Syracuse

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

20141

Istituto Europeo Di Oncologia, Milan

21201

University of Maryland, Baltimore

21287

Johns Hopkins Hospital, Baltimore

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

29425

Medical University of South Carolina - PPDS, Charleston

29609

CHRU Brest - Hospital Cavale Blanche, Brest

30322

Emory University Hospital, Atlanta

31059

Hôpital de Rangueil, Toulouse

32804

AdventHealth, Orlando

35033

CHRU Rennes, Rennes

37007

Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca

37044

CHRU Bretonneau, Tours

38043

CHU de GRENOBLE, Grenoble

38105

St Jude Children's Research Hospital, Memphis

40536

University of Kentucky, Lexington

42271

Institut de Cancerologie de la Loire, Saint-Priest-en-Jarez

43126

Azienda Ospedaliero Universitaria di Parma, Parma

43205

Nationwide Children's Hospital, Columbus

44093

CHRU Nantes, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

45122

Universitätsklinikum Essen, Essen

45220

The Christ Hospital, Cincinnati

University of Cincinnati, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

48073

William Beaumont Hospital, Royal Oak

48109

University of Michigan, Ann Arbor

48202

Henry Ford Health System, Detroit

48903

Hospital Universitario de Cruces, Barakaldo

55101

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

55454

University of Minnesota, Minneapolis

56216

Azienda Ospedaliero Universitaria Pisana, Pisa

59037

CHRU Lille, Lille

59905

Mayo Clinic - PPDS, Rochester

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi, Ancona

60153

Loyola University Medical Center, Maywood

University of Chicago Medical Center, Maywood

60611

Feinberg School of Medicine Northwestern University, Chicago

63003

Hopital Gabriel Montpied, Clermont-Ferrand

67091

Hopital de Hautepierre, Strasbourg

Hôpital Civil, Strasbourg

69004

Hôpital de La Croix Rousse, Lyon

69120

University Clinic Heidelberg - PPDS, Heidelberg

University Clinic Heidelberg - PPDS, Heidelberg

69437

Groupement Hospitalier Edouard Herriot, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70121

Ochsner Clinic Foundation, New Orleans

72076

Universitätsklinikum Tübingen, Tübingen

75015

Groupe Hospitalier Necker Enfants Malades, Paris

75390

University of Texas Southwestern Medical Center, Dallas

75475

Hôpital Saint Louis, Paris

75571

Hôpital Saint Antoine, Paris

76104

Baylor All Saints Medical Center, Fort Worth

77030

MD Anderson Cancer Center, Houston

80054

CHU Amiens Hôpital Sud, Amiens

81377

LMU Klinikum der Universität München, München

84132

University of Utah Health Sciences Center - PPDS, Salt Lake City

85724

University of Arizona, Tucson

86000

CHRU de Poitiers La Miletrie, Poitiers

87042

CHU Dupuytren, Limoges

90033

University of Southern California, Los Angeles

90095

UCLA Medical Center, Los Angeles

91010

City of Hope National Medical Center, Duarte

91054

Universitätsklinikum Erlangen, Erlangen

Universitätsklinikum Erlangen, Erlangen

92150

Hopital Foch, Suresnes

94010

Hopital Henri Mondor, Créteil

94305

Stanford University, Stanford

94800

Hôpital Paul Brousse, Villejuif

95817

UC Davis Medical Center, Sacramento

98109

Fred Hutchinson Cancer Research Center, Seattle

169608

Singapore General Hospital (SGH), Singapore

35294-0006

University of Alabama at Birmingham, Birmingham

06520

Yale University School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

02115

Brigham and Womens Hospital, Boston

01655

UMass Memorial Medical Center, Worcester

68198-5400

University of Nebraska Medical Center, Omaha

07601

Hackensack University Medical Center, Hackensack

27710-4000

Duke University Medical Center, Durham

45229-3039

Cincinnati Children's Hospital Medical Center - PIN, Cincinnati

77030-2348

Baylor College of Medicine, Houston

T6G 2G3

University of Alberta, Edmonton

L8N 3Z5

Hamilton Health Sciences Corporation, Hamilton

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

M5G 2M9

Princess Margaret Hospital, Toronto

M5G 2N2

University Health Network, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

H4A 3J1

McGill University Health Center, Montreal

04103

Universitatsklinikum Leipzig, Leipzig

00168

Fondazione Policlinico Universitario A Gemelli, Roma

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08025

Fundacio Puigvert, Barcelona

08035

Hospital Universitario Vall d'Hebrón - PPDS, Barcelona

08041

Hospital de La Santa Creu i Sant Pau, Barcelona

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

CV2 2DX

University Hospital Coventry, Coventry

B9 5SS

Birmingham Heartlands Hospital, West Midlands

G12 0YN

Beatson West of Scotland Cancer Centre - PPDS, Glasgow

W12 0HS

Imperial College Healthcare NHS Trust, London

M23 9LT

Wythenshawe Hospital - PPDS, Wythenshawe

S10 2TH

Sheffield Childrens Hospital, Sheffield

L7 8XP

Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool

NW3 2QG

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London

Royal Free Hospital, London

M13 9WL

Manchester Royal Infirmary - PPDS, Manchester

OX3 7LJ

Churchill Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT02931539 - Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir | Biotech Hunter | Biotech Hunter