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NCT00423891 · ClinicalTrials.gov registry record · Phase 1
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT00423891: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT00423891 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423891, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Medical Dictionary for Regulatory Activities (MedDRA) version 16.0 was used.
Interventions
- DRUG Entecavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2007-06-30 |
| Est. Completion | 2017-09-04 |
| Phase | Phase 1 |
What the finished NCT00423891 record still lists
NCT00423891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Entecavir is the first listed.
NCT00423891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423891 about?
NCT00423891 is a clinical study titled "A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection". The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
What is the current status of trial NCT00423891?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2007-06-30. Estimated completion is 2017-09-04.
What interventions are being tested in trial NCT00423891?
The interventions under investigation include: Entecavir (DRUG).
Who is sponsoring clinical trial NCT00423891?
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 NCT00423891's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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