Efficacy Optimizing Research of Lamivudine Therapy

A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088009

Acronym

EXPLORE

Enrollment

366

Registered

2010-03-16

Start date

2010-03-31

Completion date

2013-05-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Chronic Hepatitis B

Keywords

chronic hepatitis B

Brief 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.

Interventions

DRUGlamivudine

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

DRUGlamivudine, adefovir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
the proportion of virological breakthrough with confirmed Lamivudine resistant mutants	during 104 weeks study period

Secondary

Measure	Time frame
proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL	week 104
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104	baseline, week 104
The proportion of subjects with ALT normalization at week 104	week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104	week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104	week 104

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026