LET extension post transplant for prevention of CMV infection in HSCT
Research type
Research Study
Full title
A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post transplant in cytomegalovirus (CMV) seropositive recipients (R+) of an allogenic hematopoietic stem cell transplant (HSCT)
IRAS ID
259569
Contact name
Karl Peggs
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2018-001038-17
Duration of Study in the UK
3 years, 1 months, 17 days
Research summary
Individuals who receive stem-cell or organ transplantation undergo immunosuppressive treatments that weaken their immune system to prevent transplant rejection, leaving them vulnerable to opportunistic infections. Cytomegalovirus (CMV) is the most common viral infection after transplant, causing clinical complications and increased risk of death. Haematopoietic stem cell transplant (HSCT) recipients are at highest risk of CMV infection within approximately 100 days of transplantation. However, certain HSCT populations, whose immune systems take longer to restore after immunosuppressive treatments, can be at risk of infection beyond 100 days.
Letermovir (LET) is an inhibitor of the CMV enzyme DNA terminase, which is a protein used by the virus to make copies of itself. By inhibiting this enzyme, CMV cannot multiply, thereby preventing CMV infection.
LET has been approved in the USA and EU for the prevention (prophylaxis) of CMV infection after HSCT. It has been shown to significantly reduce the risk of CMV infection within approximately 100 days of transplantation, however, the effectiveness of prolonged (more than 100 days) LET treatment remains unclear. The purpose of this study is to assess the occurrence of CMV infection when LET prophylaxis is extended from 100 to 200 days post-transplant.
This phase 3 study will last approximately 31 months, recruiting around 216 participants, aged 18 years or over. Participants must be HSCT recipients, tested positive for CMV, who have received LET prophylaxis within 28 days after HSCT and continued through to approximately 100 days post-transplant, prior to randomisation in this study. Participants will be assigned randomly in a 2:1 ratio to one of the two treatment arms to receive either LET or a dummy drug (placebo).The study is funded by Merck Sharp & Dohme Limited and will take place at seven study centres in the UK.
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/0333
Date of REC Opinion
2 May 2019
REC opinion
Further Information Favourable Opinion