Phase 2 study in Maribavir vs Valganciclovir in CMV infections
Research type
Research Study
Full title
A PHASE 2, RANDOMIZED, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND ANTI-CYTOMEGALOVIRUS (CMV) ACTIVITY OF MARIBAVIR VERSUS VALGANCICLOVIR FOR TREATMENT OF CMV INFECTIONS IN TRANSPLANT RECIPIENTS WHO DO NOT HAVE CMV ORGAN DISEASE
IRAS ID
124997
Contact name
Magdi Yaqoob
Contact email
Sponsor organisation
Shire ViroPharma Incorporated
Eudract number
2010-024247-32
ISRCTN Number
xx
Research summary
This is a phase 2 study to assess the safety and anti-cytomegalovirus (CMV) activity of maribavir versus valganciclovir for treatment of CMV infections in patients that underwent a transplantation but do not have a CMV organ disease.
CMV is one of the most common viral infections in patients undergoing transplants.
A CMV infection can lead to serious disease involving the lungs, intestines, eyes, or a transplanted organ, among other complications.Maribavir is a new investigational anti-CMV agent that may benefit transplant recipients.
This study is being conducted to determine if maribavir may provide increased antiviral activity in the treatment of CMV infections, which some previous research studies have suggested.
The purpose of this study is to:
•Investigate whether or not maribavir is safe and effective in treating CMV infection in patients who have had a transplant and assess how well different doses of maribavir can treat CMV infection, compared to valganciclovir.
•Measure the amount of maribavir in the blood and how the body uses maribavir.
•Select the best dose of maribavir to be used in future studies.Patients will be randomly assigned to one of four treatment groups to receive oral maribavir at one of three doses : 400 or 800 or 1200 mg twice daily or valganciclovir for up to maximum 12 weeks.
Study visits (where patients might undergo physical exam, laboratory assessments, 12-lead ECG, to monitor safety and efficacy of the new drug) are performed every 1-2 weeks during the study drug treatment period (12 weeks) and every 4 weeks during the 12 weeks follow up period with a maximum of 15 scheduled visits.
This study is sponsored by ViroPharma Incorporated.
A total of 160 randomized patients is planned (40 patients in each treatment group).
We estimate to have 50 patients enrolled within UK.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/0501
Date of REC Opinion
5 Jun 2013
REC opinion
Further Information Favourable Opinion