drugset / Trial / NCT01266005

A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

NCT01266005

Phase 4 Terminated 75 enrolled Bukwang Pharmaceutical
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.

Timeline

Start
2009-08
Primary completion
2013-08
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Clevudine Small molecule 30 mg
Comparator Entecavir Small molecule 0.5 mg