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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00065507
The ClinicalTrials.gov registry entry for NCT00065507 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,622-participant average among 32 other Hepatitis B trials with a reported enrollment target (88% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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