Phase 3 Study of Brincidofovir vs. Cidofovir for Adenovirus Infection After Transplant
This study is comparing two medicines, brincidofovir (BCV) and cidofovir (CDV), for treating adenovirus (AdV) infections in people who have recently had an allogeneic hematopoietic cell transplant (allo-HCT). You might be able to join if you are at least 2 months old, had an allo-HCT within the last 180 days, and your doctor believes you need treatment for an AdV infection. The study wants to see if brincidofovir is effective in clearing the AdV infection compared to cidofovir. Success in this study means that the adenovirus infection is no longer detectable in your blood. The current status of this study is unclear, and it plans to enroll 180 participants.
- Study design
- This is a Phase 3, randomized, open-label study comparing brincidofovir with cidofovir. About 180 participants will be enrolled.
- What's involved
- You would receive either brincidofovir or cidofovir for up to 12 weeks, or until your infection clears. You will have weekly assessments through the end of treatment, and additional visits at 4 weeks after your last dose, and at Weeks 12 and 24 after starting treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- All participants will be followed for a total of 24 weeks after they are assigned to a treatment group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT
At a glance
Conditions
Where it's being run
81 sites across 36 statesStudy leadership
- Minori Rosales · STUDY_DIRECTOR · SymBio Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.Week (W) 5 Day (D) 1.
The primary efficacy endpoint is defined as AdV virological success at W5D1. -Proportion of subjects with AdV virological success