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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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 bleedi
    Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

    Current Primary Outcome:

    • Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 years ]
      Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) > 400 ng/ml


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Life quality [ Time Frame: 6 years ]
      The change of short form(SF)-36 from baseline
    • Cryoglobulinemia [ Time Frame: 6 years ]
      Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline)
    • Diabetes mellitus (DM) [ Time Frame: 6 years ]
      Number of participants without DM develop DM assessed by Ac sugar > 126 g/ml
    • Insulin resistance [ Time Frame: 6 years ]
      Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline
    • Lipid profiles [ Time Frame: 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
    • Renal disease [ Time Frame: 6 years ]
      the change of the estimated glomerular filtration rate (eGFR) from baseline


    Original Secondary Outcome: Same as current

    Information By: Kaohsiung Medical University Chung-Ho Memorial Hospital

    Dates:
    Date Received: December 21, 2016
    Date Started: August 2016
    Date Completion: September 2022
    Last Updated: February 28, 2017
    Last Verified: December 2016