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Optimized Treatment and Regression of HBV-induced Early Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

NCT01938820•Beijing Friendship Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 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.

Locations (21)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

302 Military Hospital Of China

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Key Dates

Start Date

June 1, 2013

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

July 27, 2018

Enrollment

82

ACTUAL participants

Conditions

Liver Cirrhosis

Interventions

entecavir

DRUG

Thymosin-α

DRUG

Sponsors

Lead Sponsor

Beijing Friendship Hospital

Collaborators

Peking University People's Hospital
RenJi Hospital
Peking University
Shanghai Zhongshan Hospital
Fudan University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
Nanfang Hospital, Southern Medical University
Sir Run Run Shaw Hospital
Beijing YouAn Hospital
Peking University First Hospital
Beijing 302 Hospital
Peking Union Medical College Hospital
Beijing Ditan Hospital
Beijing Tiantan Hospital
Huashan Hospital
Tongji Hospital
Tang-Du Hospital
Fifth Hospital of Shijiazhuang City
Logistics University of Chinese People's Armed Police Forces
The First Affiliated Hospital of Shanxi Medical University
The Affiliated Hospital of Yanbian University

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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