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

Conditions

• Adenovirus Infections

Eligibility Criteria

Sex

ALL

Age

2 Months - N/A

Healthy Volunteers

Not accepted

Interventions

• cidofovir — DRUG
  CDV does not have a labeled indication for treating Adenovirus infection. CDV will be administered according to local guidelines and institutional standard of care practice.
• Brincidofovir — DRUG
  Intravenous

Study Details

This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.

Key Dates

Start date

Mar 17, 2026

Status verified

Apr 2026

Primary completion

Jan 31, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IV BCV
• Active Comparator: IV CDV

Primary Outcome Measure

To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia. [ Time Frame: Week (W) 5 Day (D) 1. ]

Central Contacts

• Rochelle Maher
  +1-917-656-6951
  [email protected]

Locations (26)

Find similar trials in Phoenix, AZ

Related Studies

• A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection
  PHASE2 · Recruiting · SymBio Pharmaceuticals · Los Angeles, California