drugset / Trial / NCT00501124

Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

NCT00501124

Phase 4 Completed 70 enrolled Bukwang Pharmaceutical
RandomizedParallel-groupOpen-labelTreatment

Summary

A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.

Timeline

Start
2007-05
Primary completion
2010-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevudine Small molecule
Subject Purified hepatitis B surface antigen Vaccine