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Completed Phase 3 Interventional Results available

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

ClinicalTrials.gov ID: NCT00065507

Public ClinicalTrials.gov record NCT00065507. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 1, 2026, 1:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00065507
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
195 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2003 (Type not available)
Primary completion
Oct 2008 (Actual)
Completion
May 2013 (Actual)
Last update posted
Jun 24, 2013

2003 – 2013

United States locations

U.S. sites
16
U.S. states
13
U.S. cities
14
Facility City State ZIP Site status
Research And Education, Inc. San Diego California 92115 —
California Pacific Medical Center San Francisco California 94115 —
Yale University School Of Medicine New Haven Connecticut 06520 —
University Of Miami School Of Medicine Miami Florida 33136 —
Pediatric Gasteroenterology Atlanta Georgia 30342 —
Hawaii Medical Center East Honolulu Hawaii 96817 —
Indiana University Med Center Indianapolis Indiana 46202-5121 —
The Cht Liver Research Center Louisville Kentucky 40292 —
Johns Hopkins University Baltimore Maryland 21205 —
Henry Ford Health System Irb Detroit Michigan 48202 —
Mount Sinai Medical Center New York New York 10029 —
Columbia Presbyterian Medical Center (Cpmc) New York New York 10032 —
Integris Baptist Medical Center Oklahoma City Oklahoma 73112 —
Baylor University Medical Center Dallas Texas 75246 —
Ut Southwestern Medical Center Dallas Texas 75390-9151 —
Mcguire Dvamc Richmond Virginia 23249 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00065507, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 24, 2013 · Synced Nov 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00065507 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →