A Study of the Safety of IV Brincidofovir for Adenovirus Infection
Research type
Research Study
Full title
A RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY OF INTRAVENOUS BRINCIDOFOVIR IN ADULT ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH ADENOVIRUS VIREMIA\n
IRAS ID
235819
Contact name
Karl Peggs
Contact email
Sponsor organisation
Chimerix, Inc
Eudract number
2017-003597-14
Duration of Study in the UK
1 years, 1 months, 13 days
Research summary
This research study is to learn if an experimental drug called brincidofovir (BCV) can be used to treat adenovirus (AdV) infections in people with a bone marrow transplant. There are no approved treatments for AdV. \nThe reason for this study is to find out if BCV is a safe treatment for AdV. This will be done by comparing the effects of BCV with other treatment options called “standard of care’’. Some doctors use a drug called cidofovir. Cidofovir is approved for the treatment of an eye disease caused by a different virus. Cidofovir may also help treat AdV, but sometimes it causes damage to the kidneys. BCV is a different form of cidofovir that may be less toxic to kidneys, but this is not guaranteed.\nPatients can participate in the study if they had a bone marrow transplant within the past 100 days, had a blood test showing infection with AdV and are taking the immunosuppressant cyclosporine\nThe study will be conducted at several hospitals/clinics in the UK and Europe. About 30 people will be enrolled. Participants will either be randomised to BCV or standard of care. If they are randomized to BCV, they will receive an infusion of BCV into a vein twice a week for 2 weeks (total of 4 doses). If they still have AdV in their blood after 2 weeks, their doctor will treat them with standard of care. If they are randomized to standard of care, they will receive the same treatment that they would if not taking part in the study. They will not receive any BCV.\nThey will have at least 7 study visits to the hospital/clinic over a period of 4 weeks. People randomized to BCV will have 3 extra visits to the hospital/clinic to have blood taken during these 4 weeks. \n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1930
Date of REC Opinion
25 Jan 2018
REC opinion
Further Information Favourable Opinion