Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

Overview

The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.

Full Title of Study: “Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 2022

Clinical Trial Outcome Measures

Primary Measures

  • Sustained virological response (SVR)
    • Time Frame: 36 months
    • The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment.

Secondary Measures

  • Treatment persistence
    • Time Frame: 36 months
    • Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.
  • Virological breakthrough
    • Time Frame: 36 months
    • The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable.
  • Liver disease progression
    • Time Frame: Post treatment 10 years
    • Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
  • Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen
    • Time Frame: Post treatment 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen; – Provide written, informed consent; – Be willing and able to comply with the visit schedule and protocol-mandated procedures. Exclusion Criteria:

  • Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up time frame; – History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol. – Inability to provide written informed consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Humanity and Health Research Centre
  • Collaborator
    • Beijing 302 Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • George Lau, MD, Principal Investigator, Humanity & Health Medical Centre
  • Overall Contact(s)
    • Yudong WANG, PhD, +85228613777, danny.wang@hnhmgl.com

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