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) DNAβ€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)
First Affiliated Hospital of Guangxi Medical University
π¨π³NanNing, Guangxi, China
Xiangya Hospital Central-South Univrsity
π¨π³ChangSha, Hunan, China
HangZhou No.6 People Hospital
π¨π³Hangzhou, Zhejiang, China
ShengJing Hospital of China Medical University
π¨π³ShenYang, Liaoning, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Changhai Hospital affiliated to Second Military Medical University
π¨π³ShangHai, Shanghai, China
BeiJing YouAn Hospital ,Capital Medical University
π¨π³BeiJing, Beijing, China
Department of infectious disease, First Hospital of Peking University
π¨π³BeiJing, Beijing, China
The First People's Hospital of Foshan
π¨π³FoShan, Guangdong, China
People'S Hospital Under Beijnig University
π¨π³Beijing, Beijing, China
The Second Affiliated of ChongQing University of Medical Science
π¨π³ChongQing, Chongqing, China
Beijing Friendship Hospital Attached to the Capital Medical University
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of College of Medicine οΌZhejiang University
π¨π³HangZhou, Zhejiang, China
West China Hospital.SiChuan University
π¨π³ChengDu, Sichuan, China
Beijing Ditan Hospita
π¨π³Beijing, Beijing, China
Huashan HospitalοΌFudan University
π¨π³ShangHai, Shanghai, China
No.85 Hospital of PLA
π¨π³ShangHai, Shanghai, China
JiNan Infectious Diseases Hospital
π¨π³JINan, Shandong, China
Department of infectious disease, Nanfang Hospital
π¨π³GuangZhou, Guangdong, China
The First Affiliated Hospital of Fujian Medical University
π¨π³FuZhou, Fujian, China
First Hospital .Jilin Unniversity
π¨π³ChangChun, Jilin, China
Shanghai Ruijin Hospital
π¨π³ShangHai, Shanghai, China
Tangdu Hospital
π¨π³XiAn, Shanxi, China
GuangDong Provincial People's hospital
π¨π³GuangZhou, Guangdong, China