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

Diabetes Mellitus Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cryoglobulinemia
• Diabetes Mellitus
• Hepatitis C
• Hepatitis C, Chronic
• HepatoCellular Carcinoma
• Liver Cirrhosis
• Liver Fibroses
• Metabolic Disease
• Metabolic Diseases

• NCT number: NCT03042520
• Study type: Observational
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Wan-Long Chuang
• Phone: 0975-356064
• Email: waloch@kmu.edu.tw
• Status: Recruiting
• Start date: August 2016
• Completion date: September 2022