A Phase 3 Trial to compare IV BCV vs IV CDV for study treatment of Adenovirus viremia after allo-HCT
Research type
Research Study
Full title
A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (allo-HCT)
IRAS ID
1012759
Contact name
Koji Fukushima
Contact email
Sponsor organisation
SymBio Pharmaceuticals Limited
Research summary
After a stem cell transplant people have a weakened immune system which raises the risk of viral infections, including infections by adenovirus (AdV). In these cases, especially in children, this virus can spread in the blood and become life-threatening if not treated. Treatment with Cidofovir (CDV) is commonly used in many countries, however, currently, there is no approved therapy for treatment of AdV infection. The aim of this study is to find out if experimental medicine called Brincidofovir (BCV) is safe and how effective when given intravenously (IV, given by needle in the vein), compared to IV CDV for the treatment of AdV infections in children and adults after a stem cell transplant. This study is divided into 3 parts. The screening period includes tests, a physical exam, and a review of medical history to ensure the participant qualifies for the study. Treatment period lasts four weeks up to 12 weeks based on study doctor’s decision and on how well the participant is responding. In this study participants will be randomly assigned in a 2:1 ratio to one of two treatment groups: IV BCD or IV CDV. This means that for every three participants, two will receive BCD and one will receive CDV. In this open-label study, participants and doctors will know which treatment is given. BCV will be administered twice weekly, while CDV will be given based on the physician’s discretion. All participants will have weekly research visits during treatment, regardless of the drug assigned. The follow-up period includes 3 visits after treatment ends. During these visits, doctors will check for any side effects and perform tests to monitor the virus. The study will enrol 180 participants aged 2 months and older across approximately 90 global sites: 40 in the U.S., 30 in Europe, 8 in the UK, and 12 in other regions. The study will finish once all participants have completed treatment and follow-up visit.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0343
Date of REC Opinion
14 Nov 2025
REC opinion
Further Information Favourable Opinion