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NCT00065507 · ClinicalTrials.gov registry record · Phase 3
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
A Phase 3 study of Hepatitis B, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT00065507: Completed Phase 3 study of Hepatitis B, sponsored by Bristol-Myers Squibb.
NCT00065507 is a Phase 3 study of Hepatitis B that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 195 participants, below the 1,622-participant average among 32 other Hepatitis B trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065507, a Phase 3 study of Hepatitis B, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
Primary Outcome
Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.
Conditions Studied
Interventions
- DRUG Entecavir (ETV)
- DRUG Adefovir (ADV)
Study Locations (20)
São Paulo
- Local Institution - Sao Paulo - Sp
- Local institution - São Paulo
- Local Institution - São Paulo
California
- Research And Education, Inc. - San Diego
- California Pacific Medical Center - San Francisco
New York
- Mount Sinai Medical Center - New York
- Columbia Presbyterian Medical Center (Cpmc) - New York
Texas
- Baylor University Medical Center - Dallas
- Ut Southwestern Medical Center - Dallas
Connecticut
- Yale University School Of Medicine - New Haven
Florida
- University Of Miami School Of Medicine - Miami
Georgia
- Pediatric Gasteroenterology - Atlanta
Hawaii
- Hawaii Medical Center East - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2003-08 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT00065507 record still lists
NCT00065507 is an interventional study that assigns participants to a tested intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap, below the 1,622-participant average among 32 other Hepatitis B trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Entecavir (ETV) is the first listed.
NCT00065507 names 20 study sites across 15 states, led by São Paulo, California, New York.
Frequently Asked Questions
What is clinical trial NCT00065507 about?
NCT00065507 is a clinical study titled "Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation". This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.
What is the current status of trial NCT00065507?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2003-08. Estimated completion is 2013-05.
What conditions does trial NCT00065507 study?
This clinical trial studies the following conditions: Hepatitis B.
What interventions are being tested in trial NCT00065507?
The interventions under investigation include: Entecavir (ETV) (DRUG), Adefovir (ADV) (DRUG).
Who is sponsoring clinical trial NCT00065507?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00065507 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00065507's enrollment target sits among peer trials
195 18th of 32 higher than 15 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B 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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Entecavir to TAF Switch
ACTIVE NOT RECRUITING · Phase 3
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B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
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Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
COMPLETED · Phase 3
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Evaluation of Patients With Liver Disease
RECRUITING
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Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis
RECRUITING · Phase 4
-
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
RECRUITING · Phase 2
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