drugset / Trial / NCT01022801

A Phase II Dose Response Study in Japan in Chronic Hepatitis B

NCT01022801

Phase 2 Completed 120 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2003-08
Primary completion
2005-03
Completion
2005-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Entecavir Small molecule 0.01 mg Oral
Subject Entecavir Small molecule 0.1 mg Oral
Subject Entecavir Small molecule 0.5 mg Oral