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NCT00605384 · ClinicalTrials.gov registry record · Phase 3
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT00605384: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00605384 is a Phase 3 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00605384, a Phase 3 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.
Primary Outcome
using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA \< 50 IU/mL = approximately 300 copies/mL
Interventions
- DRUG Entecavir + Tenofovir
- DRUG Adefovir + continuing Lamivudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
Why NCT00605384 stopped before completion
NCT00605384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Entecavir + Tenofovir is the first listed.
NCT00605384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00605384 about?
NCT00605384 is a clinical study titled "A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection". The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. ...
What is the current status of trial NCT00605384?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2008-08. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00605384?
The interventions under investigation include: Entecavir + Tenofovir (DRUG), Adefovir + continuing Lamivudine (DRUG).
Who is sponsoring clinical trial NCT00605384?
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 NCT00605384's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 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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