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NCT00410072 · ClinicalTrials.gov registry record · Phase 3
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 669
- Enrollment target
NCT00410072: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00410072 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 669 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00410072, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 669 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
Primary Outcome
HBV DNA levels \<50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
Interventions
- DRUG Entecavir
- DRUG Entecavir + Tenofovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 669 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00410072 record still lists
NCT00410072 is an interventional study that assigns participants to a tested intervention. The registered 669 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 (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Entecavir is the first listed.
NCT00410072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00410072 about?
NCT00410072 is a clinical study titled "Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B". The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
What is the current status of trial NCT00410072?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 669 participants. The study started on 2007-04. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00410072?
The interventions under investigation include: Entecavir (DRUG), Entecavir + Tenofovir (DRUG).
Who is sponsoring clinical trial NCT00410072?
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 NCT00410072's enrollment target sits among peer trials
669 547th of 2000 higher than 1,453 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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