Efficacy Optimizing Research of Lamivudine Therapy

Nanfang Hospital, Southern Medical University366 enrolled

Overview

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

366

Conditions

Compensated Chronic Hepatitis B

Interventions

lamivudineDRUG

patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104

lamivudineDRUG

Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily

lamivudine, adefovirDRUG

patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18-65 years; * Capable of understanding and signing the informed consent. Willing to comply with the study requirements; * Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months; Exclusion Criteria: * History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; * other protocol defined inclusion/exclusion criteria

Locations (24)

Beijing Ditan Hospita

Outcomes

Primary Outcomes

the proportion of virological breakthrough with confirmed Lamivudine resistant mutants

Time frame: during 104 weeks study period

Secondary Outcomes

proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL

Time frame: week 104

Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104

Time frame: baseline, week 104

The proportion of subjects with ALT normalization at week 104

Time frame: week 104

The proportion of subjects with HBeAg loss and seroconversion at week 104

Time frame: week 104

The proportion of subjects with HBsAg loss and seroconversion rates at week 104

Time frame: week 104

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.