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Completed

NCT Number: NCT02578693

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

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.

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Key information

Conditions

Chronic Hepatitis C Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen

    Time frame: Post treatment 5 years

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital
  • Nanfang Hospital, Southern Medical University
  • Yamanashi Prefectural Central Hospital

Registry information

Official study title

Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2015
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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