Trial · NCT02087306
Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection
NCT02087306, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2021-08-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection. Trials, record NCT02087306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02087306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection
- NCT number
- NCT02087306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Adenovirus Infection
- Interventions
- Brincidofovir
- First posted
- 2014-03-14
- Last updated
- 2021-08-13
- Results first posted
- 2021-08-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With All-Cause Mortality | 60 days | The primary efficacy endpoint was the evaluation of the effect of brincidofovir (BCV) on all-cause mortality when used for the treatment of disseminated adenovirus (AdV) disease in all hematopoietic cell transplant (HCT) recipients. The primary endpoint associated with this objective was all-cause mortality through Day 60. |
| Secondary | Number of Participants With Reduction in Adenovirus Viremia | Assessed 13 weeks (through 7 days post-last BCV dose); during treatment up to 12 weeks reported | A secondary endpoint was the evaluation of virologic response (plasma adenovirus \[AdV\] DNA viremia) to brincidofovir treatment. Blood (plasma) was collected at screening, before dosing on Day 1 (to establish baseline), and at each subsequent assessment during the treatment and post-treatment phases for the analysis of AdV DNA viremia. All samples collected for analysis of AdV were analyzed by the designated central virology laboratory using proprietary real-time quantitative polymerase chain reaction (qPCR) assays. AdV in plasma were analyzed using the 7500 AdV qPCR Test, where the standardized assay plasma ranged from 190 copies/mL to 1 X 10\^10 copies/mL. A "positive or detectable" result referred to the measurement of AdV DNA at concentrations ≥190 copies/mL, a result below the lower limit of detection (LLOQ) (i.e., not detected) was imputed as 1 copy/mL, and a result below the lower limit of quantitation but detected will be imputed at 1 unit less than LLOQ (e.g., 189 copies/mL). |
| Secondary | Mean Minimum On-treatment Value log10 Copies/mL Change From Baseline | Baseline to 12 weeks | A secondary endpoint was the evaluation of virologic response (plasma adenovirus \[AdV\] DNA viremia) to brincidofovir treatment. Blood (plasma) was collected at screening, before dosing on Day 1 (to establish baseline), and at each subsequent assessment during the treatment and post-treatment phases for the analysis of AdV DNA viremia. All samples collected for analysis of AdV were analyzed by the designated central virology laboratory using proprietary real-time quantitative polymerase chain reaction (qPCR) assays. AdV in plasma were analyzed using the 7500 AdV qPCR Test, where the standardized assay plasma ranged from 190 copies/mL to 1 X 10\^10 copies/mL. A "positive or detectable" result referred to the measurement of AdV DNA at concentrations ≥190 copies/mL, a result below the lower limit of detection (LLOQ) (i.e., not detected) was imputed as 1 copy/mL, and a result below the lower limit of quantitation but detected will be imputed at 1 unit less than LLOQ (e.g., 189 copies/mL). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With All-Cause Mortality | 60 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Reduction in Adenovirus Viremia | Assessed 13 weeks (through 7 days post-last BCV dose); during treatment up to 12 weeks reported | Subjects with AdV viremia at baseline in the Intention-to-Treat Analysis Set. The Intention-to-Treat Analysis Set included all subjects who received at least 1 dose of BCV. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Minimum On-treatment Value log10 Copies/mL Change From Baseline | Baseline to 12 weeks | Subjects who had adenovirus viremia at baseline. | log10 copies/mL | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With All-Cause Mortality | Cohort A | 9 | Participants | ||
| Number of Participants With All-Cause Mortality | Cohort B | 27 | Participants | ||
| Number of Participants With All-Cause Mortality | Cohort C | 8 | Participants | ||
| Number of Participants With Reduction in Adenovirus Viremia | Cohort A | Undetectable AdV viremia at any time on-treatment | 30 | Participants | |
| Number of Participants With Reduction in Adenovirus Viremia | Cohort B | Undetectable AdV viremia at any time on-treatment | 52 | Participants | |
| Number of Participants With Reduction in Adenovirus Viremia | Cohort C | Undetectable AdV viremia at any time on-treatment | 17 | Participants | |
| Number of Participants With Reduction in Adenovirus Viremia | Cohort A | Undetectable AdV viremia at last on-treatment value | 25 | Participants | |
| Number of Participants With Reduction in Adenovirus Viremia | Cohort B | Undetectable AdV viremia at last on-treatment value | 41 | Participants | |
| Number of Participants With Reduction in Adenovirus Viremia | Cohort C | Undetectable AdV viremia at last on-treatment value | 16 | Participants | |
| Mean Minimum On-treatment Value log10 Copies/mL Change From Baseline | Cohort A | Minimum on-treatment value log10 copies/mL change from baseline | -2.67 | Standard Deviation 1.559 | log10 copies/mL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 65 | |
| Overall Study | STARTED | Cohort B | 93 | |
| Overall Study | STARTED | Cohort C | 43 | |
| Overall Study | COMPLETED | Cohort A | 29 | |
| Overall Study | COMPLETED | Cohort B | 29 | |
| Overall Study | COMPLETED | Cohort C | 16 | |
| Overall Study | NOT COMPLETED | Cohort A | 36 | |
| Overall Study | NOT COMPLETED | Cohort B | 64 | |
| Overall Study | NOT COMPLETED | Cohort C | 27 |
Source ClinicalTrials.gov
Adverse events520
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 | Diarrhoea | Gastrointestinal disorders | Pediatric | 58 | 130 | |
| other | Diarrhoea | Gastrointestinal disorders | Adult | 26 | 71 | |
| other | Vomiting | Gastrointestinal disorders | Pediatric | 27 | 130 | |
| other | Vomiting | Gastrointestinal disorders | Adult | 20 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | Pediatric | 20 | 130 | |
| other | Abdominal pain | Gastrointestinal disorders | Adult | 23 | 71 | |
| other | Nausea | Gastrointestinal disorders | Pediatric | 10 | 130 | |
| other | Nausea | Gastrointestinal disorders | Adult | 18 | 71 | |
| other | Abdominal distension | Gastrointestinal disorders | Pediatric | 8 | 130 | |
| other | Abdominal distension | Gastrointestinal disorders | Adult | 11 | 71 |
1 to 10 of 520Source ClinicalTrials.gov
See all 520 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pediatric | ||
| Total, all-cause mortality | Adult | ||
| Total, other adverse events | Pediatric | 127 | 130 |
| Total, other adverse events | Adult | 71 | 71 |
| Total, serious adverse events | Pediatric | 93 | 130 |
| Total, serious adverse events | Adult | 58 | 71 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pediatric vs Adult: serious adverse events |
Source 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/NCT02087306
GET https://conductscience.org/api/trials/v1/NCT02087306/events?page=2