A Phase II Dose Response Study in Japan in Chronic Hepatitis B

Bristol-Myers Squibb120 enrolled

Overview

To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Chronic Hepatitis B

Interventions

EntecavirDRUG

Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy, * Positive for HBeAg OR negative for HBeAg with positive HBeAb, * Documented HBV Viremia on 2 or more occasions: Viremia on sample drawn AND HBV DNA of ≥ 40 MEq/mL by Quantiplex assay at the screening visit

Outcomes

Primary Outcomes

Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)

Time frame: at Week 22

Secondary Outcomes

Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine

Time frame: Through Week 24 (end of dosing) plus 5 days

Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine

Time frame: Through Week 24 (end of dosing) plus 5 days

HBV DNA as measured by PCR (log10 copies/mL) at Week 22 [to demonstrate non-inferiority of at least one dose of entecavir as compared with lamivudine]

Time frame: Week 22

Proportion of subjects in each treatment group who achieve HBV DNA reduced by ≥2 log10 and/or below the limit of quantification (LOQ) (<400 copies/mL) as measured by PCR assay

Time frame: Week 12, Week 22

Proportion of subjects in each treatment group who achieve HBV DNA below the limit of detection (0.7 MEq/mL) of the Quantiplex branched DNA hybridization assay (Quantiplex assay)

Time frame: Week 22

Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)

Time frame: Week 22

Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline

Time frame: Baseline, Week 22

Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline

Data from ClinicalTrials.gov

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