A Phase 2 interventional study of Entecavir in Chronic Hepatitis B, sponsored by Bristol-Myers Squibb. Completed at 16 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-31.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The objectives are to demonstrate that entecavir has antiviral activity undetectable HBV DNA measured, the Roche AmplicorTM PCR at Week 48, and to assess the safety and the pharmacokinetic of entecavir in Japanese patients with hepatitis B who have an incomplete response to current lamivudine therapy
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 84 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Documentation of chronic hepatitis B infection by ALL of the following:
Exclusion Criteria:
-
Drug: Entecavir
Drug: Entecavir
Tablet, P.O., 0.5 mg or 1mg, once daily, 52 weeks
Also known as: Baraclude, BMS-200475
To assess the safety (the incidence of clinical adverse events and discontinuations due to adverse events)
Time frame: Week 52 (end of dosing) plus 5 days
To assess the proportion of subjects with reduction in HBV DNA by ≥ 2 log10 or to undetectable level (< 400 copies/mL)
Time frame: at Week 48
Mean change from baseline in the log*10* HBV DNA measured by PCR assay for each entecavir dose (0.5 and 1 mg) at Week 48
Time frame: Baseline, Week 48
Proportion of subjects who achieve undetectable HBV DNA (<400 copies/mL) by PCR assay at Week 48
Time frame: Week 48
Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum at Week 48
Time frame: Week 48
Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb) at Week 48
Time frame: Week 48
Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT (<1.25 x ULN) at Week 48
Time frame: Week 48
Proportion of subjects HBeAg-positive at baseline who have complete response (undetectable HBV DNA levels by PCR assay, negative for HBeAg and normal serum ALT) at Week 48
Time frame: Week 48
Proportion of subjects HBeAg-negative at baseline who have undetectable HBV DNA levels by PCR assay, remain negative for HBeAg and normal serum ALT at Week 48
Time frame: Week 48
Proportion of subjects w/ histological improvement in liver (improvement in necroinflammatory score (≥2 points decrease, Knodell HAI3 score) & no worsening of fibrosis (≥1 point increase, Knodell fibrosis score) at Wk 48 liver biopsy compared to baseline
Time frame: Baseline, Week 48
Changes in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis
Time frame: Week 52
Relationship between HBV isolates (genotypes A,B,C, etc.) at baseline and antiviral activity
Time frame: Week 48, or at end of dosing (up to Week 52)
Incidence of resistance mutations of HBV isolates in subjects who have a rise in HBV DNA (by ≥1 log above the nadir for that subject) while on study drug.
Time frame: Week 48, or at end of dosing (up to Week 52)
Mutation of HBV DNA polymerase at Week 48 from baseline
Time frame: Baseline, Week 48
Plasma concentrations of entecavir at selected time points during the treatment period
Time frame: pre-dosing, Week 2 or 4, Week 12, Week 24 and Week 36
Population pharmacokinetic assessment of entecavir developed from concentration-time data obtained from healthy subjects
Time frame: pre-dosing, Week 2 or 4, Week 12, Week 24 and Week 36
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb