Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients
NCT02849132 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2021-04-28
Summary
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.
Conditions
Interventions
- DRUG
-
Entecavir
oral entecavir 0.5mg daily for 8 years
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
Fudan University
collaborator OTHER -
Affiliated Hospital of Yanbian University
collaborator UNKNOWN -
Shanghai Public Health Clinical Center
collaborator OTHER_GOV -
Beijing YouAn Hospital
collaborator OTHER -
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Beijing Friendship Hospital
lead OTHER
Principal Investigators
-
Xiaojuan Ou · Beijing Friendship Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2023-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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