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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02578693

Enrollment

1210

Registered

2015-10-19

Start date

2015-05-15

Completion date

2024-07-31

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen	Post treatment 5 years	—

Countries

China, Japan

Outcome results