Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
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;
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.