Clinical trial NCT01022801: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)
timeFrame: at Week 22
Secondary outcomes:
measure: Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine
timeFrame: Through Week 24 (end of dosing) plus 5 days
measure: Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine
timeFrame: Through Week 24 (end of dosing) plus 5 days
measure: 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]
timeFrame: Week 22
measure: 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
timeFrame: Week 12, Week 22
measure: 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)
timeFrame: Week 22
measure: Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)
timeFrame: Week 22
measure: Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline
timeFrame: Baseline, Week 22
measure: Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline
timeFrame: Week 22
measure: 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)
timeFrame: Week 22
measure: 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)
timeFrame: Week 22
measure: 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
timeFrame: Through Week 24
measure: Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response
timeFrame: Week 22
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: