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Efficacy Optimizing Research of Lamivudine Therapy

Phase 4
Completed
Conditions
Compensated Chronic Hepatitis B
Interventions
Registration Number
NCT01088009
Lead Sponsor
Nanfang Hospital, Southern Medical University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
366
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
early add-onlamivudine-
De-novo combinationlamivudine, adefovirpatients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks
SOClamivudinePatients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
Primary Outcome Measures
NameTimeMethod
the proportion of virological breakthrough with confirmed Lamivudine resistant mutantsduring 104 weeks study period
Secondary Outcome Measures
NameTimeMethod
proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mLweek 104
The proportion of subjects with HBeAg loss and seroconversion at week 104week 104
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104baseline, week 104
The proportion of subjects with ALT normalization at week 104week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104week 104

Trial Locations

Locations (24)

Beijing Ditan Hospita

🇨🇳

Beijing, Beijing, China

Beijing Friendship Hospital Attached to the Capital Medical University

🇨🇳

Beijing, Beijing, China

BeiJing YouAn Hospital ,Capital Medical University

🇨🇳

BeiJing, Beijing, China

Department of infectious disease, First Hospital of Peking University

🇨🇳

BeiJing, Beijing, China

People'S Hospital Under Beijnig University

🇨🇳

Beijing, Beijing, China

The Second Affiliated of ChongQing University of Medical Science

🇨🇳

ChongQing, Chongqing, China

The First Affiliated Hospital of Fujian Medical University

🇨🇳

FuZhou, Fujian, China

The First People's Hospital of Foshan

🇨🇳

FoShan, Guangdong, China

Department of infectious disease, Nanfang Hospital

🇨🇳

GuangZhou, Guangdong, China

GuangDong Provincial People's hospital

🇨🇳

GuangZhou, Guangdong, China

Scroll for more (14 remaining)
Beijing Ditan Hospita
🇨🇳Beijing, Beijing, China

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