Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive

• Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen

• Prior entecavir and/or tenofovir monotherapy is allowed

• Subjects must have compensated liver function

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Evidence of decompensated cirrhosis

• Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

• Moderate or severe renal impairment

• Recent history of pancreatitis

• Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study

• Prior entecavir/tenofovir combination therapy