An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection
- Registration Number
- NCT01037062
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 282
Inclusion Criteria
-
Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
-
ALT ≤ 10 x upper limit of normal;
-
Subjects must have well-compensated liver disease according to ALL of the following criteria;
- Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
- Serum albumin ≥ 3 g/dL (≥ 30 g/L)
- Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)
Exclusion Criteria
- Sex and Reproductive Status Exceptions
- Target Disease Exceptions
- Medical History and Concurrent Diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entecavir Entecavir -
- Primary Outcome Measures
Name Time Method To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy 24 weeks
- Secondary Outcome Measures
Name Time Method Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing Incidence of laboratory abnormalities of of entecavir for each cohort Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum Day 1, Week 12, Week 24 and every subsequent 24 week during dosing Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) Day 1, Week 12, Week 24 and every subsequent 24 week during dosing Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48 Day 1, Week 48 Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ) Day 1, Week 12, 24, and subsequent 24 week during dosing Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion Week 8, 16, 24 post dosing Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug 24 Week post dosing Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study] Week 48, 96 NChanges in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis Week 48 & Week 96 Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days
Trial Locations
- Locations (1)
Local Institution
🇯🇵Tokyo, Japan