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NCT00096785 · ClinicalTrials.gov registry record · Phase 3

Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

A Phase 3 study of Chronic Disease and Hepatitis B, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
69
Enrollment target
20
Study locations

NCT00096785: Completed Phase 3 study of Chronic Disease and Hepatitis B, sponsored by Bristol-Myers Squibb.

NCT00096785 is a Phase 3 study of Chronic Disease and Hepatitis B that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 69 participants, below the 89,942-participant average among 48 other Chronic Disease trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00096785, a Phase 3 study of Chronic Disease and Hepatitis B, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
69 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Primary Outcome

Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.

Interventions

  • DRUG entecavir
  • DRUG adefovir

Study Locations (20)

Other

  • Local Institution - Chai Wan
  • Local Institution - Pokfulham
  • Local Institution - Tai Po
  • Local Institution - Jakarta
  • Local Institution - Cebu
  • Local Institution - Manila

California

  • Local Institution - San Diego
  • Local Institution - San Francisco
  • Local Institution - Torrance

Florida

  • Local Institution - Miami
  • Local Institution - North Miami Beach

New York

  • Local Insitution - New York
  • Local Institution - New York

Texas

  • Local Institution - Dallas
  • Local Institution - Galveston

Maryland

  • Local Institution - Baltimore

Pennsylvania

  • Local Institution - Philadelphia

Alberta

  • Local Institution - Edmonton

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2004-12
Est. Completion 2008-04
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00096785 record still lists

NCT00096785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 89,942-participant average among 48 other Chronic Disease trials with a reported enrollment target (100% lower).

The record links to 2 conditions, with Chronic Disease appearing as the primary indexed condition, and to 2 interventions - of which entecavir is the first listed.

NCT00096785 names 20 study sites across 10 states, led by Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00096785 about?

NCT00096785 is a clinical study titled "Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection". The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

What is the current status of trial NCT00096785?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2004-12. Estimated completion is 2008-04.

What conditions does trial NCT00096785 study?

This clinical trial studies the following conditions: Chronic Disease, Hepatitis B.

What interventions are being tested in trial NCT00096785?

The interventions under investigation include: entecavir (DRUG), adefovir (DRUG).

Who is sponsoring clinical trial NCT00096785?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00096785 being conducted?

This trial has 20 study locations across California, Florida, Maryland, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Chronic Disease

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 NCT00096785's enrollment target sits among peer trials

69 39th of 48 higher than 10 of 48 other Chronic Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Disease 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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Source: ClinicalTrials.gov NCT00096785, the US trial registry maintained by the National Library of Medicine. NCT00096785 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.