Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

Bristol-Myers Squibb84 enrolled

Overview

The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis B

Interventions

EntecavirDRUG

Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documentation of chronic hepatitis B infection by ALL of the following: 1. Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy 2. Patient who have received lamivudine therapy for 24 weeks or more, or patient who have documented YMDD mutation or other lamivudine-resistant mutation while on lamivudine 3. Documented HBV Viremia ≥ 10\*5: copies/mL * ALT in the range of 1.3 to 10 x ULN * Subjects must have well-compensated liver disease a) value Exclusion Criteria: \-

Locations (16)

Local Institution

Aichi-Gun, Aichi-ken, Japan

Local Institution

Nagoya, Aichi-ken, Japan

Local Institution

Nagoya, Aichi-ken, Japan

Outcomes

Primary Outcomes

To assess the safety (the incidence of clinical adverse events and discontinuations due to adverse events)

Time frame: Week 52 (end of dosing) plus 5 days

To assess the proportion of subjects with reduction in HBV DNA by ≥ 2 log10 or to undetectable level (< 400 copies/mL)

Time frame: at Week 48

Secondary Outcomes

Mean change from baseline in the log*10* HBV DNA measured by PCR assay for each entecavir dose (0.5 and 1 mg) at Week 48

Time frame: Baseline, Week 48

Proportion of subjects who achieve undetectable HBV DNA (<400 copies/mL) by PCR assay at Week 48

Time frame: Week 48

Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum at Week 48

Time frame: Week 48

Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) at Week 48

Time frame: Week 48

Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT (<1.25 x ULN) at Week 48

Time frame: Week 48

Proportion of subjects HBeAg-positive at baseline who have complete response (undetectable HBV DNA levels by PCR assay, negative for HBeAg and normal serum ALT) at Week 48

Time frame: Week 48

Proportion of subjects HBeAg-negative at baseline who have undetectable HBV DNA levels by PCR assay, remain negative for HBeAg and normal serum ALT at Week 48

Time frame: Week 48

Data from ClinicalTrials.gov

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