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

NCT00065507 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2013-06-24

Study results available
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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

Interventions

DRUG

Entecavir (ETV)

Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized

DRUG

Adefovir (ADV)

Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2008-10-31
Completion
2013-05-31

Countries

  • United States
  • Brazil
  • Canada
  • France
  • Greece
  • Hong Kong
  • India
  • Indonesia
  • Philippines
  • Poland
  • Russia
  • Singapore
  • South Africa
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00065507 on ClinicalTrials.gov