NCT01938820·Phase 4·INTERVENTIONAL

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Thymosin Alpha-1 Other Completed

Status

Completed

Phase

Phase 4

Enrollment

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

entecavir

anti-viral therapy

DRUG

Thymosin-α

antiviral and antifibrosis therapy

Timeline

From registration to results.

First posted
Sep 10, 2013
Study start
Jun 2013
Primary completion
Dec 2016
Study completion
Dec 2016
Results posted
Not reported
Registry updated
Jul 27, 2018

Outcomes

What the study measures.

Primary outcomes

Regression of HBV-induced liver cirrhosis

Time frame · 1.5 to 2 years

Liver cirrhosis regression of 1 point by Ishak scoring system

Secondary outcomes

Child-Pugh score

Time frame · 1 year and 2 years

Child-Pugh score change after 1 and 2-year treatment

HBVDNA undetectable rate

Time frame · 1 year and 2 years

The HBVDNA undetectable rate after 1 and 2-year treatment.

Fibroscan value

Time frame · 1 year and 2 years

Fibroscan value change after 1 and 2-year treatment

Life Quality

Time frame · 1 year and 2 years

Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: 65 Years
Sex: ALL
Healthy volunteers: No

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.

Study locations