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.

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NCT07387367

A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

Recruiting
PHASE3Ages 2+InterventionalTreatment
SymBio Pharmaceuticals
~180 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:cidofovirBrincidofovir

At a glance

Recruiting sites
35 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.
Measured over Week (W) 5 Day (D) 1.
Adenovirus Infections
81 sites across 36 states
France9
Germany8
United Kingdom8
Italy5
California4
Spain4
New York3
Canada3
  • Minori Rosales · STUDY_DIRECTOR · SymBio Pharmaceuticals

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Eligibility criteria

Inclusion

AdV viremia DNA ≥10,000 IU/mL, OR
Two consecutive and rising AdV viremia DNA results of ≥1,000 IU/mL at screening, OR
AdV viremia DNA of ≥1,000 IU/mL, AND
  • 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