NCT04251572

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

May 30, 2018

Last Update Submit

August 25, 2021

Conditions

Hepatitis C Virus Infection, Response to Therapy ofDrug Use

Outcome Measures

Primary Outcomes (1)

  • Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy

    Number of reinfections with hepatitis C per 100 persons

    up to two years

Secondary Outcomes (2)

  • questionnaire to Identify risk factors associated with HCV reinfection

    day 1

  • questionaire to Identify risk factors associated with HCV reinfection

    up to 2 years

Study Arms (1)

HCV reinfection after DAA therapy in PWID

EXPERIMENTAL

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 samplingOther: questionaires

Interventions

Blood samplingOTHER

Blood sampling

HCV reinfection after DAA therapy in PWID
questionairesOTHER

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.

HCV reinfection after DAA therapy in PWID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Blood sample drawn within 6 months pre-treatment stored at -70° C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Free Clinic Antwerp

Antwerp, 2000, Belgium

RECRUITING

ZNA Stuivenberg

Antwerp, 2000, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

AZ Maria-Middelares

Ghent, 9000, Belgium

RECRUITING

CAD Limburg

Hasselt, 3500, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

CHC Saint-Josephe, Liège

Liège, 4000, Belgium

RECRUITING

Sint-Trudo Ziekenhuis

Sint-Truiden, 3800, Belgium

RECRUITING

AZ Vesalius

Tongeren, 3700, Belgium

RECRUITING

Related Publications (1)

  • Busschots D, Bielen R, Koc OM, Heyens L, Verrando R, de Galocsy C, Van Steenkiste C, Nevens F, Midgard H, Dalgard O, Robaeys G. Hepatitis C reinfection in former and active injecting drug users in Belgium. Harm Reduct J. 2021 Oct 12;18(1):102. doi: 10.1186/s12954-021-00552-x.

    PMID: 34641896DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Geert Robaeys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Rob Bielen, dr.

    Hasselt University

    STUDY CHAIR

Central Study Contacts

Geert Robaeys, prof. dr.

CONTACT

+32 89 32 15 60geert.robaeys@zol.be

Rob Bielen, dr.

CONTACT

+32 89 32 15 60rob.bielen@zol.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2018

First Posted

February 5, 2020

Study Start

July 1, 2019

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

BE(10)