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

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Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

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.

Background information
Trial ID: 
NCT00065507
Other unique IDs: 
AI463-048
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

Detailed description: 

 

Number to be enrolled: 
220 patients
Clinical information
Age groups: 
Adult
Senior
Child
Gender: 
Both
Eligibility criteria: 

Inclusion

  • CP score >= 7
  • HBV viremia

Exclusion

  • ALT > 15 x ULN
  • HIV/HCV/HDV coinfection

Study design: 
Treatment
Randomized
Active Control
Safety/Efficacy Study
Open Label
Parallel Assignment
Interventions: 
Adefovir
Entecavir
Conditions treated: 
Hepatitis B
Funding
Funding types: 
INDUSTRY
Sponsor: 
Bristol-Myers Squibb
Dates
Date the data was first received: 
Mon, 2003-07-28
Trial start date: 
Fri, 2003-08-01
Trial completion date: 
Wed, 2013-05-01
Trial last updated: 
Wed, 2009-05-20