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NCT03339401 · ClinicalTrials.gov registry record · Phase 2
The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT03339401: Clinical Trial Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT03339401 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03339401, a Phase 2 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy endpoint for this study was the time-averaged area under the concentration-time curve for plasma adenovirus (AdV) viremia (log10 copies/mL) from randomization through Week 16 post-randomization. Due to the small number of subjects enrolled in the study, formal efficacy analyses were not performed. Individual subject AdV viremia profiles show the differential anti-adenoviral effect of brincidofovir (BCV) in comparison to standard of care (SoC) therapy.
Interventions
- OTHER Standard of Care
- DRUG Brincidofovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2019-05-10 |
| Phase | Phase 2 |
Why NCT03339401 stopped before completion
NCT03339401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03339401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03339401 about?
NCT03339401 is a clinical study titled "The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation". 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 hemato...
What is the current status of trial NCT03339401?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2017-12-22. Estimated completion is 2019-05-10.
What interventions are being tested in trial NCT03339401?
The interventions under investigation include: Standard of Care (OTHER), Brincidofovir (DRUG).
Who is sponsoring clinical trial NCT03339401?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03339401's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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