Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- Cryoglobulinemia
- Diabetes Mellitus
- Hepatocellular Carcinoma
- Liver Fibroses
- Metabolic Disease
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
Primary Endpoint: To evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including HCC, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in CHC patients. Secondary Endpoints: To evaluate ...
Primary Endpoint: To evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including HCC, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in CHC patients. Secondary Endpoints: To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy. To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy. To evaluate long-term effect of sofosbuvir-based therapy on the extra-hepatic manifestations of the cohort. The items include mixed cryoglobulinemia, chronic kidney diseases, insulin resistance, diabetic status, cardiovascular events and dyslipidemia. To evaluate long-term effect of sofosbuvir-based therapy on quality of life on the cohort. Study Design Prospective, longitudinal observational study Study procedure A total of 200 patients receiving sofosbuvir based direct antiviral agents (DAAs) in the parent studies will be included for following up to 5 years. Their serological, image study and disease status description will be prospectively documented to present the long term effects of sofosbuvir-based therapy. The presentation of illness will be specified as: Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality. Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.
Tracking Information
- NCT #
- NCT03042520
- Collaborators
- Chang Gung Memorial Hospital
- National Taiwan University Hospital
- National Cheng-Kung University Hospital
- Dong-A University Hospital
- Chi Mei Medical Hospital
- China Medical University, China
- Korea University Guro Hospital
- Inje University
- Mackay Memorial Hospital
- Taipei Veterans General Hospital, Taiwan
- Soon Chun Hyang University
- Seoul National University Bundang Hospital
- Gachon University Gil Medical Center
- Changhua Christian Hospital
- Pusan National University Hospital
- Severance Hospital
- Asan Medical Center
- Gangnam Severance Hospital
- Korea University
- Seoul National University Hospital
- Seoul St. Mary's Hospital
- Kyungpook National University Hospital
- Samsung Medical Center
- Investigators
- Study Director: Ming-Lung Yu Kaoshiung Medical University Hospital Principal Investigator: Chia-Yen Dai Kaoshiung Medical University Hospital Principal Investigator: Jee-Fu Huang Kaoshiung Medical University Hospital Principal Investigator: Chung-Feng Huang Kaoshiung Medical University Hospital Principal Investigator: Ming-Lun Yeh Kaoshiung Medical University Hospital Principal Investigator: Ching-I Huang Kaoshiung Medical University Hospital Principal Investigator: Ta-Wei Liu Kaoshiung Medical University Hospital
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