Overview

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Friendship Hospital
Collaborators:
Beijing 302 Hospital
Beijing Ditan Hospital
Beijing Tiantan Hospital
Beijing YouAn Hospital
Fifth Hospital of Shijiazhuang City
Fudan University
Huashan Hospital
Logistics University of Chinese People's Armed Police Forces
Nanfang Hospital of Southern Medical University
Peking Union Medical College Hospital
Peking University
Peking University First Hospital
Peking University People's Hospital
RenJi Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Shanghai Zhongshan Hospital
Sir Run Run Shaw Hospital
Tang-Du Hospital
The Affiliated Hospital of Yanbian University
The First Affiliated Hospital of Shanxi Medical University
Tongji Hospital
Treatments:
Entecavir
Criteria
Inclusion Criteria:

1. Patients from age 18 to 65 years old;

2. Male or female;

3. 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;

4. Patients with HBeAg-positive, HBVDNA>2×10<3>IU/ml or patients with HBeAg-negative,
HBVDNA>2×10<2> IU/ml;

5. Agree to be followed up regularly;

6. Signature of written informed consent.

Exclusion Criteria:

1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy,
esophageal varices bleeding or other complications of decompensated cirrhosis or
hepatocelluar carcinoma;

2. Patients who are allergic to entecavir, thymosin or their components, and those
considered not suitable for drugs used in this study;

3. 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;

4. 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;

5. Creatinine >1.5×ULN;

6. Patients with other uncured malignant tumors;

7. Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;

8. Patients with any other reasons not suitable for the study.