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NCT01079806 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT01079806: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01079806 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01079806, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
Primary Outcome
Suppression=HBV DNA\<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
Interventions
- DRUG Placebo
- DRUG Entecavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2010-06-30 |
| Est. Completion | 2018-03-31 |
| Phase | Phase 3 |
What the finished NCT01079806 record still lists
NCT01079806 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01079806 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01079806 about?
NCT01079806 is a clinical study titled "A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection". The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
What is the current status of trial NCT01079806?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2010-06-30. Estimated completion is 2018-03-31.
What interventions are being tested in trial NCT01079806?
The interventions under investigation include: Placebo (DRUG), Entecavir (DRUG).
Who is sponsoring clinical trial NCT01079806?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01079806's enrollment target sits among peer trials
180 1422nd of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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