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

Completed

• Conditions: Chronic Hepatitis C Infection

• Registration Number: NCT02578693
• Lead Sponsor: Humanity and Health Research Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-19
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virological response (SVR)	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 Outcome Measures

Name	Time	Method
Virological breakthrough	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	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.
Treatment persistence	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.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen	Post treatment 5 years

Trial Locations

Locations (3)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital; 🇨🇳 Beijing, Beijing, China

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China

Yamanashi Prefectural Central Hospital; 🇯🇵 Kofu-city, Yamanashi, Japan