CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 195 enrolled
Drug / intervention
Entecavir (ETV) +1 moredrug
Likely dose
Entecavir 1 mg orally once daily or Adefovir 10 mg orally once dailyAI-extracted
Key inclusion· 2
  • ✓Child-Pugh score ≥7 (evidence of hepatic decompensation)
  • ✓Hepatitis B virus (HBV) viremia documented
Key exclusion· 2
  • ✕Alanine aminotransferase (ALT) >15× upper limit of normal
  • ✕HIV/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00065507
NCT00065507Phase 3Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Jul 29, 2003·Updated Jun 24, 2013

In Brief

A Phase 3 clinical trial evaluating Entecavir (ETV) and Adefovir (ADV) for Hepatitis B. Completed, enrolled 195 participants across 61 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesBrazil, Canada, France, Greece, Hong Kong, India, Indonesia, Philippines, Poland, Russia, Singapore, South Africa, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2003
Enrollment StartAug 1, 2003
Primary CompletionOct 1, 2008
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 22.9 years ago

Interventions

Entecavir (ETV)drug

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

Adefovir (ADV)drug

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