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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Adefovir; Adefovir dipivoxil; Entecavir; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• Chronic HBV infection

• History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit

• Compensated liver function

• HBV DNA ≥ 172,000 IU/mL

• Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative

Exclusion Criteria:

• Evidence of decompensated cirrhosis

• Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)

• Recent history of pancreatitis

• Serum alpha fetoprotein > 100 ng/mL

• Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B