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Efficacy Optimizing Research of Lamivudine Therapy

NCT01088009 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2013-10-30

No results posted yet for this study

Summary

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.

Conditions

  • Compensated Chronic Hepatitis B

Interventions

DRUG

lamivudine

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

DRUG

lamivudine

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

DRUG

lamivudine, adefovir

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

Sponsors & Collaborators

  • Major Science and Technology Special Project of China Eleventh Five-year

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • JinLin Hou, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-02-28
Completion
2013-05-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01088009 on ClinicalTrials.gov