Open label Study with Maribavir and Investigator-Assigned Tx for CMV
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir.
IRAS ID
212745
Contact name
Bhuvan Kishore
Contact email
Sponsor organisation
Shire ViroPharma Incorporated
Eudract number
2015-004725-13
Clinicaltrials.gov Identifier
Investigational New Drug (IND), IND 051001
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
This study targets patients who have had a stem cell transplant or organ transplant and were diagnosed with a Cytomegalovirus infection (CMV). CMV is a viral infection and can happen in transplant patients. In patients with certain conditions such as transplant or weak defense system, CMV can become active and they can have symptoms of the disease. When CMV is active, it can be found in the blood.
This investigational study is for patients who are not responding to the current treatment for their CMV infection. The word “investigational” means that a medicine is being tested and is not approved by a regulatory agency outside the use in clinical studies.
No approved therapies for the treatment of CMV infection or disease in
transplant recipients are available, and no approved treatment for CMV infection or disease that is resistant or refractory to currently available therapies in any population.Maribavir (the study drug) is currently under development for the treatment of CMV infection or disease, including those resistant or refractory to ganciclovir, valganciclovir, foscarnet, or cidofovir, in transplant recipients.
This Phase 3 open label study is designed to further assess and demonstrate the efficacy and safety of maribavir, dosed at 400 mg twice daily, compared to investigator-assigned anti-CMV agent of choice for the treatment of CMV infections that are resistant or refractory to treatment with ganciclovir,valganciclovir, foscarnet, or cidofovir in transplant recipients.
Participants will be in the study approximately 22 weeks. Some patients may be in the study up to 29 weeks. Approximately 351 patients, age 12 or older will participate in approximately 100 sites in 18 countries, with approximately 35 participants expected to take part in the UK. As of December 2014, approximately 1,262 patients have received maribavir in clinical studies.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0448
Date of REC Opinion
21 Dec 2016
REC opinion
Further Information Favourable Opinion