Entecavir Plus Adefovir in Lamivudine-Resistant Patients
Phase 4
Withdrawn
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT00986778
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entecavir plus Adefovir Adefovir - Lamivudine plus Adefovir Lamivudine - Entecavir plus Adefovir Entecavir - Entecavir Entecavir - Lamivudine plus Adefovir Adefovir -
- Primary Outcome Measures
Name Time Method The proportion of patients with HBV DNA < 50 IU/mL at W48 Week 48
- Secondary Outcome Measures
Name Time Method Mean reduction of HBV DNA at W 48 & 96 Week 48 and 96 The proportion of subjects with ALT normalization at W 48 & 96 Week 48 & Week 96 The proportion of patient with HBV DNA < 50 IU/mL at W 96 Week 96 The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96 Week 48 & 96 Safety Week 48 and Week 96 Resistance Week 48 & Week 96