Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Lamivudine (Drug); Entecavir (Drug); Adefovir (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Official title: A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The proportion of patients with HBV DNA < 50 IU/mL at W48

Secondary outcome:

The proportion of patient with HBV DNA < 50 IU/mL at W 96

Mean reduction of HBV DNA at W 48 & 96

The proportion of subjects with ALT normalization at W 48 & 96

The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96

Safety

Resistance

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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)

Starting date: December 2009
Ending date: June 2014
Last updated: September 29, 2009