The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
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
Outcome
Outcome not reported
Stopped (Enrollment): “terminated due to low enrollment rate”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brincidofovir | Other / unclassified | 1.4 mg/kg | Oral |
| Subject | Brincidofovir | Other / unclassified | 2 mg/kg | Oral |
| Subject | Brincidofovir | Other / unclassified | 100 mg | Oral |