Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

June 21, 2019

Primary Completion Date

October 27, 2021

Study Completion Date

March 16, 2022

Conditions
Cytomegalovirus Infection
Interventions
DRUG

Letermovir

LET tablet or intravenous infusion at a total daily dose of 240 mg (when given with cyclosporin A) or 480 mg (when given alone).

DRUG

Placebo

Placebo was administered as tablets matched to LET or as inactive (saline or dextrose) intravenous infusion.

Trial Locations (32)

10065

Memorial Sloan Kettering Cancer Center ( Site 0164), New York

20132

IRCCS Ospedale San Raffaele ( Site 0051), Milan

25123

ASST Spedali Civili di Brescia ( Site 0052), Brescia

27710

Duke University Medical Center ( Site 0169), Durham

33136

University of Miami, Sylvester Comprehensive Cancer Center ( Site 0160), Miami

34295

Hopital Saint Eloi ( Site 0031), Montpellier

46237

Indiana Blood and Marrow Transplantation ( Site 0175), Indianapolis

48149

Universitaetsklinikum Muenster ( Site 0043), Münster

50937

Universitaetsklinik Koeln ( Site 0041), Cologne

69120

Universitaetsklinikum Heidelberg-Medizinische Klinik V ( Site 0042), Heidelberg

69495

Centre Hopitalier Lyon Sud ( Site 0039), Pierre-Bénite

75012

CHU Hopital Saint Antoine ( Site 0036), Paris

77030

The University of Texas MD Anderson Cancer Center ( Site 0154), Houston

87042

Centre Hospitalier Universitaire Dupuytren ( Site 0182), Limoges

91010

City of Hope National Medical Center ( Site 0158), Duarte

94110

CHU Henri Mondor ( Site 0032), Créteil

94805

Institut Gustave Roussy ( Site 0038), Villejuif

95817

University of California Davis Medical Center ( Site 0156), Sacramento

98109

Fred Hutchinson Cancer Research Center ( Site 0152), Seattle

02115

Brigham & Women's Hospital ( Site 0161), Boston

07601

John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0174), Hackensack

00133

Fondazione PTV Policlinico Tor Vergata ( Site 0054), Roma

00161

Policlinico Umberto I ( Site 0056), Roma

00168

Policlinico Universitario Agostino Gemelli ( Site 0055), Roma

329-0498

Jichi Medical University Hospital ( Site 0123), Shimotsuke

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 0121), Hiroshima

860-0008

National Hospital Organization Kumamoto Medical Center ( Site 0122), Kumamoto

G51 4TF

Queen Elizabeth University Hospital [Glasgow, UK] ( Site 0096), Glasgow

SE5 9RS

1Kings College Hospital ( Site 0091), London

WC1E 6BT

UCL Cancer Institute ( Site 0093), London

M13 9WL

Manchester Royal Infirmary ( Site 0097), Manchester

NE7 7DN

Freeman Hospital Newcastle upon Tyne Foundation NHS Trust ( Site 0092), Newcastle upon Tyne

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03930615 - Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) | Biotech Hunter | Biotech Hunter