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

Phase 2

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Entecavir

• Registration Number: NCT01022801
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Disposition First Submitted: 2010-01-29
• Disposition First Submitted QC: 2010-01-29
• Last Update Submitted: 2010-01-29
• Disposition First Posted: 2010-02-02
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir (0.01 mg)	Entecavir	-
Entecavir (0.5 mg)	Entecavir	-
Entecavir (0.1 mg)	Entecavir	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)	at Week 22

Secondary Outcome Measures

Name	Time	Method
Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine	Through Week 24 (end of dosing) plus 5 days
Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine	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]	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	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)	Week 22
Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)	Week 22
Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline	Baseline, Week 22
Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline	Week 22
Proportion of HBeAg-positive subjects at baseline who achieve responder status (defined as: HBV DNA <0.7 MEq/mL by the Quantiplex assay; loss of HBeAg and normal serum ALT)	Week 22
Proportion of HBeAg-negative subjects at baseline who achieve responder status (defined as HBV DNA <0.7 MEq/mL by the Quantiplex assay and normal serum ALT)	Week 22
Incidence of genotypic resistance of HBV isolates in subjects who have a ε 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug	Through Week 24
Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response	Week 22