Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
NCT03753074 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 780
Last updated 2024-12-17
Summary
Treatment with Tenofovir Alafenamide(TAF) in Chronic Hepatitis B (CHB) patients classified as beyond treatment indication of current international guidelines (e.g. aged more than 40 years old and 4 ≤ log HBV-DNA IU/mL \< 8) is expected to bring improvement in long-term clinical outcomes. This expected result may expand the treatment indications in patients with CHB based on age and HBV-DNA in contrast to current international guidelines of CHB.
Conditions
Interventions
- DRUG
-
Tenofovir Alafenamide 25mg, Tablet, Oral, Daily
Sponsors & Collaborators
-
Samsung Medical Center
collaborator OTHER -
Kyunghee University Medical Center
collaborator OTHER -
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
collaborator OTHER -
Seoul National University Hospital
collaborator OTHER -
Ulsan University Hospital
collaborator OTHER -
Konkuk University Medical Center
collaborator OTHER -
Kyungpook National University Hospital
collaborator OTHER -
Korea University Guro Hospital
collaborator OTHER -
Seoul St. Mary's Hospital
collaborator OTHER -
Kaohsiung Medical University
collaborator OTHER -
Chang Gung Memorial Hospital
collaborator OTHER -
E-DA Hospital
collaborator OTHER -
Taitung Mackay Memorial Hospital
collaborator UNKNOWN -
National Cheng-Kung University Hospital
collaborator OTHER -
Chi Mei Medical Hospital
collaborator OTHER -
Chiayi Christian Hospital
collaborator OTHER -
St. Martin De Porress Hospital
collaborator OTHER -
Dalin Tzu Chi General Hospital
collaborator OTHER -
Taichung Veterans General Hospital
collaborator OTHER -
China Medical University Hospital
collaborator OTHER -
Seoul National University Bundang Hospital
collaborator OTHER -
Young-Suk Lim
lead OTHER
Principal Investigators
-
Young-Suk Lim, M.D, Ph D · Asan Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-18
- Primary Completion
- 2031-12-31
- Completion
- 2031-12-31
Countries
- South Korea
Study Locations
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