A Phase II Dose Response Study in Japan in Chronic Hepatitis B
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
1 other identifier
interventional
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedFebruary 2, 2010
November 1, 2009
1.6 years
November 30, 2009
January 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)
at Week 22
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (3)
Entecavir (0.01 mg)
EXPERIMENTALEntecavir (0.1 mg)
EXPERIMENTALEntecavir (0.5 mg)
EXPERIMENTALInterventions
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 1, 2009
Study Start
August 1, 2003
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
February 2, 2010
Record last verified: 2009-11