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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR LETERMOVIR


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All Clinical Trials for Letermovir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02137772 ↗ Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001) Completed Merck Sharp & Dohme Corp. Phase 3 2014-06-06 The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through Week 24 post-transplant.
NCT03443869 ↗ Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002) Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2018-05-03 The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
NCT03728426 ↗ Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection Recruiting Merck Sharp & Dohme Corp. Phase 2 2019-01-11 The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
NCT03728426 ↗ Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection Recruiting Amy C. Sherman, MD Phase 2 2019-01-11 The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
NCT03728426 ↗ Letermovir Treatment for Refractory or Resistant Cytomegalovirus Infection Recruiting Dana-Farber Cancer Institute Phase 2 2019-01-11 The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.
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) Active, not recruiting Merck Sharp & Dohme Corp. Phase 3 2019-06-21 The purpose of this study is to evaluate the safety and efficacy of letermovir (LET) versus placebo when extended from 100 days to 200 days post-transplant in cytomegalovirus (CMV) seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It is hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days.
NCT03940586 ↗ Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030) Recruiting Merck Sharp & Dohme Corp. Phase 2 2019-08-08 The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Letermovir

Condition Name

Condition Name for Letermovir
Intervention Trials
Cytomegalovirus Infections 5
Cytomegalovirus Disease 2
Cytomegalovirus Infection 2
Chronic Lymphocytic Leukemia 2
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Condition MeSH

Condition MeSH for Letermovir
Intervention Trials
Cytomegalovirus Infections 10
Infections 9
Communicable Diseases 7
Infection 7
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Clinical Trial Locations for Letermovir

Trials by Country

Trials by Country for Letermovir
Location Trials
United States 46
France 12
Germany 8
Australia 8
Japan 7
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Trials by US State

Trials by US State for Letermovir
Location Trials
California 5
Massachusetts 5
New York 5
Washington 3
Pennsylvania 3
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Clinical Trial Progress for Letermovir

Clinical Trial Phase

Clinical Trial Phase for Letermovir
Clinical Trial Phase Trials
Phase 4 2
Phase 3 5
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Letermovir
Clinical Trial Phase Trials
Not yet recruiting 8
Recruiting 6
Active, not recruiting 4
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Clinical Trial Sponsors for Letermovir

Sponsor Name

Sponsor Name for Letermovir
Sponsor Trials
Merck Sharp & Dohme Corp. 11
National Cancer Institute (NCI) 2
Assistance Publique - Hôpitaux de Paris 2
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Sponsor Type

Sponsor Type for Letermovir
Sponsor Trials
Other 13
Industry 12
NIH 4
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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Johnson and Johnson
McKinsey
AstraZeneca
Moodys

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