drugset / Trial / NCT03339401

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

NCT03339401

Phase 2 Terminated 29 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

Timeline

Start
2017-12-22
Primary completion
2019-05-10
Completion
2019-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Brincidofovir Other / unclassified 1.4 mg/kg Oral
Subject Brincidofovir Other / unclassified 2 mg/kg Oral
Subject Brincidofovir Other / unclassified 100 mg Oral