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Effect of Entecavir Treatment on Regression and Long-term Disease Outcome in Patients With HBV-induced Liver Fibrosis and Cirrhosis (Regress Extension Study)
Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.
Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Peking University First 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
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NanfangHospital,Southern Medical University
Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China
Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology
Wuhan, Hubei, China
Start Date
January 1, 2016
Primary Completion Date
December 1, 2023
Completion Date
December 1, 2025
Last Updated
April 28, 2021
800
ESTIMATED participants
Entecavir
DRUG
Lead Sponsor
Beijing Friendship Hospital
Collaborators
NCT07024641
NCT06671093
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
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View ClinicalTrials.gov Terms and ConditionsNCT06169592