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news.ViroPharma, a biopharmaceutical company, has discontinued its Phase III trial evaluating maribavir used as prophylaxis against cytomegalovirus disease in liver transplant patients. The company also plans to move all the patients on study drug to the current standard of care.
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The decision was made based on the results of the Phase III study of maribavir in stem cell transplant patients, and the recommendation from the independent data monitoring committee who considered the rate of viremia in both arms of the study.
This Phase III study was a randomized, double-blind, multicenter study intended to enroll 348 subjects who have undergone liver transplantation and are at high risk of developing cytomegalovirus (CMV) disease (donor CMV seropositive/recipient CMV seronegative). Following transplantation, eligible subjects were randomized to receive maribavir 100mg BID or oral ganciclovir 1,000mg TID in a 1:1 allocation ratio for up to 14 weeks.
If CMV disease, defined as symptomatic CMV infection or CMV organ disease, occurred during the study drug administration period, study drug will be discontinued and the subject will be managed according to standard CMV treatment practices at the transplant center, the company said.
The primary efficacy endpoint was the incidence of CMV disease (either symptomatic CMV infection or CMV organ disease) within six months post transplantation, which is expected to be approximately 12% in the oral ganciclovir arm of the study, based on data from published literature.