Phase 3 study of Maribavir vs Valganciclovir in CMV infection in HSCT
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients
IRAS ID
220763
Contact name
Karl Peggs
Contact email
Sponsor organisation
Shire ViroPharma, Incorporated
Eudract number
2015-004726-34
Clinicaltrials.gov Identifier
IND 051001, IND
Duration of Study in the UK
2 years, 3 months, 5 days
Research summary
Summary of Research
This is a multicentre study of maribavir compared to valganiciclovir for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell recipients.There are currently no anti-viral drugs specifically approved for treatment of CMV infection in transplant recipients. Ganciclovir, approved for the treatment of CMV retinitis in patients with compromised immune systems, and valganciclovir, approved for treatment of CMV retinitis in patients with HIV/AIDS and prevention of CMV disease in solid organ transplant recipients, are widely used in clinical practice to treat CMV infection. However, the most common side effect of this treatment is bone marrow suppression, which is of particular concern for hematopoietic stem cell transplant (HSCT) recipients.
Maribavir is currently in development for the treatment of CMV infection or disease. Maribavir may be of particular benefit to HSCT patients as it does not appear to cause bone marrow suppression.
The study is funded by Shire ViroPharma, Inc. Approximately 612 participants will be considered for the study with around 550 participants expected to be treated globally. Approximately 36 participants are expected to be treated in the UK.
Participants will be randomized in a 1:1 ratio (50 / 50 chance) to a double-blind treatment with maribavir 400mg twice a day or valganciclovir 900mg twice a day. (Double-blind treatment means that neither the participant nor study doctor will know which treatment is being received).
The study will have 3 phases: (1) Up to a 2-week screening phase; (2) 8-week treatment phase; and (3) 12-week follow-up phase. Participants will be required to visit the site up to 18 times for up to a 22-week period.
This study involves procedures including: Medical history, physical examinations, vital signs, performance status, ECG (electrocardiogram), blood tests and questionnaires.
Summary of Results
The primary goal of the study to determine if maribavir was a better for clearing cytomegalovirus from the blood compared to valganciclovir at 8 weeks of treatment was not met. Overall, maribavir was well tolerated in this study and had fewer side effects that would limit taking the treatment compared to valganciclovir.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1149
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion