A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Lamivudine Placebo; Drug: Lamivudine; Drug: Entecavir; Drug: Entecavir Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393484

AI463-105

Details and patient eligibility

About

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Enrollment: 122 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Nucleoside and nucleotide-naive subjects with chronic HBV infection
• Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
• Detectable HBsAg
• HBV DNA ≥ 105 copies/mL by PCR
• ALT 1.3 to 10 x the ULN
• HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

Arm A

Experimental group

Description:

Entecavir + Lamivudine placebo (0-96 weeks) Entecavir (96-240 weeks)

Treatment:

Drug: Lamivudine Placebo

Drug: Entecavir

Arm B

Active Comparator group

Description:

Lamivudine + Entecavir placebo (0-96 weeks) Lamivudine (96-240 weeks)

Treatment:

Drug: Entecavir Placebo

Drug: Lamivudine