Optimized Treatment and Regression of HBV-induced Early Cirrhosis
- Registration Number
- NCT01938820
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- Patients from age 18 to 65 years old;
- Male or female;
- Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;
- Patients with HBeAg-positive, HBVDNA>2×10<3>IU/ml or patients with HBeAg-negative, HBVDNA>2×10<2> IU/ml；
- Agree to be followed up regularly;
- Signature of written informed consent.
- Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;
- Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases;
- Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;
- Creatinine >1.5×ULN;
- Patients with other uncured malignant tumors;
- Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;
- Patients with any other reasons not suitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entecavir plus Thymosin-α Thymosin-α entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year. Entecavir Therapy entecavir Entecavir monotherapy: entecavir, 0.5mg, qd, oral, for 2 years. Entecavir plus Thymosin-α entecavir entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
- Primary Outcome Measures
Name Time Method Regression of HBV-induced liver cirrhosis 1.5 to 2 years Liver cirrhosis regression of 1 point by Ishak scoring system
- Secondary Outcome Measures
Name Time Method HBVDNA undetectable rate 1 year and 2 years The HBVDNA undetectable rate after 1 and 2-year treatment.
Child-Pugh score 1 year and 2 years Child-Pugh score change after 1 and 2-year treatment
Fibroscan value 1 year and 2 years Fibroscan value change after 1 and 2-year treatment
Life Quality 1 year and 2 years Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Trial Locations
- Locations (21)
Peking University
🇨🇳Beijing, Beijing, China
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
🇨🇳Tianjin, Tianjin, China
Beijing Ditan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing YouAn Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shijiazhuang Fifth Hospital
🇨🇳Shijiazhuang, Hebei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆Technology
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Yanbian University
🇨🇳Yanji, Jilin, China
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
🇨🇳Shanghai, Shanghai, China
Huashan Hospital, FuDan University
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
302 Military Hospital Of China
🇨🇳Beijing, Beijing, China