HCV Reinfection After DAA Therapy in PWID in Belgium (REINF_HCV)

August 25, 2021 updated by: Geert Robaeys, Hasselt University

Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium, 2000
        • Recruiting
        • Free Clinic Antwerp
        • Contact:
          • Catharina Mathëi, MD
          • Phone Number: +32 32 01 12 60
        • Contact:
          • Maertens Griet, nurse
        • Principal Investigator:
          • Catharina Mathëi, MD
      • Antwerp, Belgium, 2000
        • Recruiting
        • ZNA Stuivenberg
        • Contact:
        • Principal Investigator:
          • Stefan Bourgeois, dr.
      • Bruxelles, Belgium, 1000
      • Genk, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dana Busschots, drs.
        • Sub-Investigator:
          • Eefje Dercon, nurse
      • Gent, Belgium, 9000
        • Recruiting
        • AZ Maria-Middelares
        • Contact:
        • Principal Investigator:
          • Christophe Van Steenkiste, dr.
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Filip Janssens, dr.
      • Hasselt, Belgium, 3500
        • Recruiting
        • CAD Limburg
        • Contact:
        • Principal Investigator:
          • Rita Verrando, dr.
      • Liège, Belgium, 4000
        • Recruiting
        • CHC Saint-Josephe, Liège
        • Contact:
        • Contact:
          • Annick Deflandre, study nurse
        • Principal Investigator:
          • Boris Bastens, prof. dr.
      • Sint-Truiden, Belgium, 3800
        • Recruiting
        • Sint-Trudo ziekenhuis
        • Contact:
        • Principal Investigator:
          • luc Van Den Bergh, dr.
      • Tongeren, Belgium, 3700
        • Recruiting
        • AZ Vesalius
        • Contact:
        • Principal Investigator:
          • Annelies Posen, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Criteria:

  • Patients not fulfilling the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HCV reinfection after DAA therapy in PWID
Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.
Other: Blood sampling
Blood sampling
Other: questionaires
Included participants will complete a baseline questionnaire at end of treatment (EOT) and a follow-up questionnaire throughout the follow-up period (Table 1). The questionnaires collect information on socio-demographics (age, gender, ethnicity, employment status, education level, housing status, incarceration, medical history and OST), injecting drug use (drugs injected, injection frequency and sharing of needle/syringe, cookers, cotton/filter or water). Details on the received DAA regime including mode of administration (direct observed therapy, pill box, etc.) and self-reported data on treatment adherence will also be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy
Time Frame: up to two years
Number of reinfections with hepatitis C per 100 persons
up to two years

Secondary Outcome Measures

Outcome Measure
Time Frame
questionnaire to Identify risk factors associated with HCV reinfection
Time Frame: day 1
day 1
questionaire to Identify risk factors associated with HCV reinfection
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Jessa Hospital
Ziekenhuis Netwerk Antwerpen (ZNA)
Ziekenhuis Oost-Limburg
Algemeen Ziekenhuis Maria Middelares
Centre Hospitalier Universitaire Saint Pierre
Clinique Saint Joseph, Liège
Algemeen Ziekenhuis Vesalius
CAD Limburg
Sint-Trudo
Free Clinic Antwerp

Investigators

  • Study Chair: Rob Bielen, dr., Hasselt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ANTICIPATED)

February 28, 2022

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/0012U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Use

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe