Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Hepatitis B
- Liver Cirrhosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT02849132
- Collaborators
- Peking University People's Hospital
- Fudan University
- Affiliated Hospital of Yanbian University
- Shanghai Public Health Clinical Center
- Beijing YouAn Hospital
- Nanfang Hospital of Southern Medical University
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Principal Investigator: Xiaojuan Ou Beijing Friendship Hospital
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