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

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: telbivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT01270165

4-2010-0168

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)