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

• Status: Unknown status
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Adefovir; Adefovir dipivoxil; Lamivudine; Telbivudine

Criteria

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