Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Adefovir; Drug: Lamivudine; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986778

AI463-195

Details and patient eligibility

About

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

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Lamivudine plus Adefovir

Active Comparator group

Treatment:

Drug: Lamivudine

Drug: Adefovir

Entecavir

Active Comparator group

Treatment:

Drug: Entecavir

Entecavir plus Adefovir

Experimental group

Treatment:

Drug: Entecavir

Drug: Adefovir