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

Yonsei University110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Chronic Hepatitis B

Interventions

telbivudineDRUG

600mg, oral daily over 12 months

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Virologic response

Time frame: 1 year

Secondary Outcomes

Safety, virologic breakthrough and biochemical response

Time frame: 1 year

Central Contacts

Han Jak Ryu, Dr.

CONTACT

+82-10-2329-2379 hanjak@yuhs.ac

Data from ClinicalTrials.gov

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