Trial · NCT03339401
The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
NCT03339401, Phase 2, Terminated, Jazz Pharmaceuticals; results first posted 2021-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation. Trials, record NCT03339401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03339401
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation
- NCT number
- NCT03339401
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Adenovirus
- Interventions
- Standard of Care, Brincidofovir
- First posted
- 2017-11-13
- Last updated
- 2021-01-25
- Results first posted
- 2021-01-25
- Limitations and caveats
The study was terminated in May 2019 due to poor subject accrual rates. As a result, statistical analyses were not performed. Limited demographic, efficacy, and safety data are provided for the 29 subjects who were enrolled as descriptive summaries.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-averaged Area Under the Concentration-time Curve for Plasma Adenovirus Viremia (Log10 Copies/mL). | From randomization to 16 weeks post-randomization | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-averaged Area Under the Concentration-time Curve for Plasma Adenovirus Viremia (Log10 Copies/mL). | From randomization to 16 weeks post-randomization | The time-averaged area under the concentration-time curve for plasma adenovirus (AdV) viremia was not calculated because many of the viral response data were arbitrarily truncated/censored and individual subject AdV viremia profiles cannot be reported due to concerns with patient confidentiality. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brincidofovir | 20 | |
| Overall Study | STARTED | Standard of Care | 9 | |
| Overall Study | COMPLETED | Brincidofovir | 11 | |
| Overall Study | COMPLETED | Standard of Care | 5 | |
| Overall Study | NOT COMPLETED | Brincidofovir | 9 | |
| Overall Study | NOT COMPLETED | Standard of Care | 4 |
Source ClinicalTrials.gov
Adverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Brincidofovir | 2 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care | 0 | 9 | |
| other | Evans Syndrome | Blood and lymphatic system disorders | Brincidofovir | 0 | 20 | |
| other | Evans Syndrome | Blood and lymphatic system disorders | Standard of Care | 1 | 9 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Brincidofovir | 2 | 20 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Standard of Care | 0 | 9 | |
| other | Haemolytic uraemic syndrome | Blood and lymphatic system disorders | Brincidofovir | 3 | 20 | |
| other | Haemolytic uraemic syndrome | Blood and lymphatic system disorders | Standard of Care | 0 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | Brincidofovir | 2 | 20 | |
| other | Neutropenia | Blood and lymphatic system disorders | Standard of Care | 2 | 9 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brincidofovir | 4 | 20 |
| Total, all-cause mortality | Standard of Care | 1 | 9 |
| Total, other adverse events | Brincidofovir | 20 | 20 |
| Total, other adverse events | Standard of Care | 9 | 9 |
| Total, serious adverse events | Brincidofovir | 15 | 20 |
| Total, serious adverse events | Standard of Care | 6 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brincidofovir vs Standard of Care: deaths from any cause | Trial comparisons |
| Brincidofovir vs Standard of Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03339401
GET https://conductscience.org/api/trials/v1/NCT03339401/events?page=2