Entecavir Plus Adefovir in Lamivudine-Resistant Patients

• Status: Withdrawn
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I

• Naïve to nucleoside/nucleotide analogues except for LVD

• HBV DNA > 17,200 IU/mL

• Compensated liver function

• Serum ALT <10 × ULN

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Evidence of decompensated cirrhosis

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