NCT03042520

Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment

Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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: 1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment. 2. To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.

Detailed 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: 1. To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy. 2. To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy. 3. 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. 4. 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: 1. Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality. 2. Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.

Conditions

• Liver Fibroses
• HepatoCellular Carcinoma
• Cryoglobulinemia
• Metabolic Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Observation only

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-02-03
• Last updated: 2021-10-12

Locations

26 sites across 2 countries: South Korea, Taiwan