A Phase II Study of IV BCV in Subjects with Adenovirus Infection
Research type
Research Study
Full title
A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Brincidofovir in Subjects with Adenovirus Infection
IRAS ID
1004556
Contact name
Phillip Farrell
Contact email
Sponsor organisation
SymBio Pharmaceuticals Limited
Eudract number
2020-005945-17
Clinicaltrials.gov Identifier
NCT 04706923
Research summary
The purpose of this study is to assess the safety, tolerability, and efficacy of different doses and schedules of intravenous treatment with the study drug, brincidofovir, in adult and paediatric participants (aged 2 months and older) with adenovirus viremia (AdV), who have either (a) disseminated AdV disease or (b) an underlying immunocompromised state, and have asymptomatic AdV infection or localised AdV disease.
A total of 24 participants will take part in this study. There will be 4 treatment cohorts, and each cohort will consist of 6 participants. Each cohort will have a different dose of the study drug, calculated on the basis of the participant’s body weight. This is a dose escalation study which means the first participant cohort will receive an initial dose listed for their weight. If that dose is found to be safe after several participants have received it, the next participants to enrol will receive a different, higher, dose.
This is an open-label study, so the participant and study doctor will know what treatment the participant will be receiving.
Participants will take part in this study for at least approximately 9 weeks, which includes the screening period (1 week), receiving the study drug for 4 weeks, and being monitored for 30 days (approximately 4 weeks), after their last dose of the study drug. If the participant is not hospitalised, they will need to come to the study centre at least 11 times over the study period. If their virus infection is not cleared after 4 weeks, the treatment with the study drug might be continued for a maximum of 14 weeks, depending on their condition and the study doctor’s decision.
The study will take place at approximately 12 sites in the UK and US.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0095
Date of REC Opinion
9 May 2022
REC opinion
Further Information Unfavourable Opinion