drugset / Trial / NCT00605384

A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

NCT00605384

Phase 3 Terminated 4 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.

Timeline

Start
2008-08
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Adefovir Unknown 10 mg Oral
Subject Entecavir Small molecule 1 mg Oral
Subject Lamivudine Other / unclassified 100 mg Oral
Subject Tenofovir Small molecule 300 mg Oral