Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment (LONGHEAD)
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- STATUS
- Recruiting
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- days left to enroll
- 90
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- participants needed
- 200
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- sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Summary
Primary Objective:
To evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment.
Secondary Objective:
- To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.
- To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.
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 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.
Details
| Condition | Liver Fibroses, HepatoCellular Carcinoma, Cryoglobulinemia, Metabolic Disease, Diabetes Mellitus |
|---|---|
| Treatment | Observation only |
| Clinical Study Identifier | NCT03042520 |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Last Modified on | 24 February 2022 |
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