Efficacy Optimizing Research of Lamivudine Therapy
- 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
- 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;
- 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
Group Intervention Description early add-on lamivudine - De-novo combination lamivudine, adefovir patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks SOC lamivudine Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
- Primary Outcome Measures
Name Time Method the proportion of virological breakthrough with confirmed Lamivudine resistant mutants during 104 weeks study period
- Secondary Outcome Measures
Name Time Method proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL week 104 The proportion of subjects with HBeAg loss and seroconversion at week 104 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 HBsAg loss and seroconversion rates at week 104 week 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