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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Completed PHASE4 INTERVENTIONAL NCT01938820

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: entecavir
Type: DRUG
Description: anti-viral therapy
Name: Thymosin-α
Type: DRUG
Description: antiviral and antifibrosis therapy

Primary Outcomes

Measure: Regression of HBV-induced liver cirrhosis
TimeFrame: 1.5 to 2 years
Description: Liver cirrhosis regression of 1 point by Ishak scoring system

Trial Information

NCT ID

NCT01938820

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Beijing Friendship Hospital

Last Updated

December 15, 2025