Trial | NCT01943617  Report issue

Official Title

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    606
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;
Study Started
Jun 30
2013
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Jul 27
2018

Drug Entecavir

anti-viral therapy

  • Other names: Entecavir dispersible tablets

Drug Thymosin-α

anti-viral and antitherapy

  • Other names: Zadaxin

Entecavir Therapy Active Comparator

Entecavir, 0.5mg, qd, oral, for 2 years

Entecavir plus thymosin therapy Experimental

Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year

Criteria 

Inclusion Criteria:

Patients from age 18 to 65 years ;
Male or female;

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

endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension

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)
HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml;
Agree to be followed up regularly;
Signature of written inform consent.

Exclusion Criteria:

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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 system or other organs;
Patients with any other reasons not suitable for the study.
No Results Posted