Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;

• 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; 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 ;

2. Male or female;

3. Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);

1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension

2. if no endoscopy,should meet two of the four Criterias:

• Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity

• Platelet (PLT) < 100×10 < 9 >/L , no other interpretation

• Albumin (ALB) < 35.0 g/L, or International Standard Value (INR) > 1.3 (Prothrombin Time (PT) prolonged > 3s), or Cholinesterase (CHE) decrease

• Liver stiffness measurement value > 12.4 kpa (ALT<5×ULN)

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

5. Agree to be followed up regularly;

6. Signature of written inform 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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 system or other organs;

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