Efficacy Optimizing Research of Lamivudine Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Compensated Chronic Hepatitis B

Keywords

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chronic hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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early add-on

Group Type EXPERIMENTAL

lamivudine

Intervention Type DRUG

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

SOC

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

Group Type ACTIVE_COMPARATOR

lamivudine

Intervention Type DRUG

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

De-novo combination

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

Group Type OTHER

lamivudine, adefovir

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

lamivudine

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

Intervention Type DRUG

lamivudine, adefovir

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JinLin Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

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