Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

Phase 3

• Conditions: Chronic Hepatitis B

• Registration Number: NCT01270165
• Lead Sponsor: Yonsei University

Brief Summary

No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02
• Primary Completion: 2012-05
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• HBeAg positive
• lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
• HBV DNA over 300 copies/ml

Exclusion Criteria

• decompensated cirrhosis
• renal failure
• prior interferon usage
• evidence of HCC or prior organ transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Virologic response	1 year

Secondary Outcome Measures

Name	Time	Method
Safety, virologic breakthrough and biochemical response	1 year

Trial Locations

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of