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

• Conditions: Diabetes Mellitus; Liver Fibroses; HepatoCellular Carcinoma; Cryoglobulinemia; Metabolic Disease

• Registration Number: NCT03042520
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-10
• Last Update Posted: 2021-10-12
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment	6 years	Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation
Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment	6 years	Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation
Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment	6 years	Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) \> 400 ng/ml

Secondary Outcome Measures

Name	Time	Method
Life quality	6 years	The change of short form(SF)-36 from baseline
Cryoglobulinemia	6 years	Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline)
Diabetes mellitus (DM)	6 years	Number of participants without DM develop DM assessed by Ac sugar \> 126 g/ml
Insulin resistance	6 years	Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline
Renal disease	6 years	the change of the estimated glomerular filtration rate (eGFR) from baseline
Lipid profiles	6 years	Change of the serum profile of lipids including triglyceride(TG), cholesterol(Chol), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) from baseline

Trial Locations

Locations (26)

Korea University Ansan Hospital; 🇰🇷 Ansan, Korea, Republic of

Asan Medical Center; 🇰🇷 Asan, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon.; 🇰🇷 Bucheon, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Gachon University Gil Hospital; 🇰🇷 Incheon, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

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