drugset / Trial / NCT00065507

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

NCT00065507

Phase 3 Completed 195 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adefovir Unknown 10 mg Oral
Subject Entecavir Small molecule 1 mg Oral