Back to resultsA Phase II Dose Response Study in Japan in Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Entecavir (0.01 mg)
Entecavir (0.1 mg)
Entecavir (0.5 mg)
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)
Secondary Outcome Measures
Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine
Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine
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]
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
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)
Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)
Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline
Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline
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)
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)
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
Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response
Full Information
NCT ID
NCT01022801
First Posted
November 30, 2009
Last Updated
January 29, 2010
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01022801
Brief Title
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
Official Title
A Phase II Study in Japan of the Safety and Antiviral Activity of Entecavir (BMS-200475) vs Lamivudine in Adults With Chronic Hepatitis B Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Entecavir (0.01 mg)
Arm Type
Experimental
Arm Title
Entecavir (0.1 mg)
Arm Type
Experimental
Arm Title
Entecavir (0.5 mg)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude, BMS-200475
Intervention Description
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Primary Outcome Measure Information:
Title
Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)
Time Frame
at Week 22
Secondary Outcome Measure Information:
Title
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
Title
Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine
Time Frame
Through Week 24 (end of dosing) plus 5 days
Title
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
Title
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
Title
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
Title
Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)
Time Frame
Week 22
Title
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
Title
Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline
Time Frame
Week 22
Title
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)
Time Frame
Week 22
Title
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)
Time Frame
Week 22
Title
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
Time Frame
Through Week 24
Title
Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response
Time Frame
Week 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
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