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Adenovirus InfectionsChildren's healthDrugPhase 3

What this study is

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.

What's being tested

  • cidofovir

    Intervention · 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

    Intervention · DRUG

    Intravenous

Study details

Official 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)
Sponsor
SymBio Pharmaceuticals
Conditions
Adenovirus Infections
Enrolling
180 people
Starts
2026-03-17
Est. completion
2028-06-30
Design
Single-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗