HCV Reinfection After DAA Therapy in PWID in Belgium

Last updated: August 25, 2021
Sponsor: Hasselt University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Drug Use

Treatment

N/A

Clinical Study ID

NCT04251572
18/0012U
  • Ages > 18
  • All Genders

Study Summary

The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population.

Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent
  • Age 18 years or older
  • Injecting drug use within 6 months before start of treatment
  • Achieved an ETR following at least eight weeks of DAA treatment
  • Completed DAA treatment no more than 6 months prior to inclusion
  • Blood sample drawn within 6 months pre-treatment stored at -70° C

Exclusion

Exclusion Criteria:

  • Patients not fulfilling the inclusion criteria.

Study Design

Total Participants: 100
Study Start date:
July 01, 2019
Estimated Completion Date:
February 28, 2022

Study Description

This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users.

Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.

Connect with a study center

  • Free Clinic Antwerp

    Antwerp, 2000
    Belgium

    Active - Recruiting

  • ZNA Stuivenberg

    Antwerp, 2000
    Belgium

    Active - Recruiting

  • CHU Saint-Pierre

    Bruxelles, 1000
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Active - Recruiting

  • AZ Maria-Middelares

    Gent, 9000
    Belgium

    Active - Recruiting

  • CAD Limburg

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • CHC Saint-Josephe, Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • Sint-Trudo Ziekenhuis

    Sint-Truiden, 3800
    Belgium

    Active - Recruiting

  • AZ Vesalius

    Tongeren, 3700
    Belgium

    Active - Recruiting

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