Follow up of IFN Vs DAAs HCV SVR (IFDACS 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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Hepatitis C Infection

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Yudong WANG, PhD; Phone Number: +85228613777; Email: danny.wang@hnhmgl.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
      • Contact: Guofeng Chen, MD
      • Principal Investigator: Guofeng Chen, MD
      • Principal Investigator: Dong Ji, MD
  • Hong Kong
    • Hong Kong, Hong Kong, China, 00852
      • Recruiting
      • Humanity and Health GI and Liver Centre
      • Contact: George Lau, MD
      • Principal Investigator: George Lau, MD
• Japan
  • Yamanashi
    • Kofu-city, Yamanashi, Japan, 400-8506
      • Recruiting
      • Yamanashi Prefectural Central Hospital
      • Contact: Masao Omata, MD
      • Principal Investigator: Masao Omata, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained virological response (SVR)	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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment persistence	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.	36 months
Virological breakthrough	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.	36 months
Liver disease progression	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.	Post treatment 10 years
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen		Post treatment 5 years

Collaborators and Investigators

• Sponsor: Humanity and Health Research Centre
• Collaborators: Beijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi Prefectural Central Hospital
• Investigators: Principal Investigator: George Lau, MD, Humanity & Health Medical Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Infections; Hepatitis; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic
• Other Study ID Numbers: H&H_HCV IFN Vs DAAs Fu