EFFicacy Optimization Research of Telbivudine Therapy

Nanfang Hospital, Southern Medical University606 enrolled

Overview

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

606

Conditions

Hepatitis B, Chronic

Interventions

telbivudineDRUG

telbivudine, 600mg, oral, daily

telbivudineDRUG

telbivudine, 600mg, oral, daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, from 18 (inclusive) to 65 (inclusive) years of age * HBsAg and HBeAg positive for over six months * Patient is willing and able to comply with the study drug regimen and all other study requirements * Patients must give written informed consent before any assessment is performed Exclusion Criteria: * Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit * Patient has a history of or clinical signs/symptoms of hepatic decompensation * Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC * Other protocol-defined inclusion/exclusion criteria may apply

Locations (24)

302 Military Hospital of China

Outcomes

Primary Outcomes

To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II

Time frame: Week 104

Secondary Outcomes

Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52

Time frame: week 52

Serum HBV DNA reduction from baseline at week 104

Time frame: week 104

Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline

Time frame: week 104

Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline

Time frame: week 104

Serum HBV DNA reduction from baseline at week 52

Time frame: week 52

Data from ClinicalTrials.gov

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