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

Primary Purpose

Hepatitis C Virus Infection, Response to Therapy of, Drug Use

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sampling
questionaires
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis C Virus Infection, Response to Therapy of

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Free Clinic AntwerpRecruiting
  • ZNA StuivenbergRecruiting
  • CHU Saint-PierreRecruiting
  • Ziekenhuis Oost-LimburgRecruiting
  • AZ Maria-MiddelaresRecruiting
  • CAD LimburgRecruiting
  • Jessa ZiekenhuisRecruiting
  • CHC Saint-Josephe, LiègeRecruiting
  • Sint-Trudo ZiekenhuisRecruiting
  • AZ VesaliusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCV reinfection after DAA therapy in PWID

Arm Description

Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

questionnaire to Identify risk factors associated with HCV reinfection
questionaire to Identify risk factors associated with HCV reinfection

Full Information

First Posted
May 30, 2018
Last Updated
August 25, 2021
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg, Jessa Hospital, Algemeen Ziekenhuis Vesalius, CAD Limburg, Sint-Trudo, Free Clinic Antwerp, Ziekenhuis Netwerk Antwerpen (ZNA), Clinique Saint Joseph, Liège, Centre Hospitalier Universitaire Saint Pierre, Algemeen Ziekenhuis Maria Middelares
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1. Study Identification

Unique Protocol Identification Number
NCT04251572
Brief Title
HCV Reinfection After DAA Therapy in PWID in Belgium
Acronym
REINF_HCV
Official Title
Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg, Jessa Hospital, Algemeen Ziekenhuis Vesalius, CAD Limburg, Sint-Trudo, Free Clinic Antwerp, Ziekenhuis Netwerk Antwerpen (ZNA), Clinique Saint Joseph, Liège, Centre Hospitalier Universitaire Saint Pierre, Algemeen Ziekenhuis Maria Middelares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection, Response to Therapy of, Drug Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCV reinfection after DAA therapy in PWID
Arm Type
Experimental
Arm Description
Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention.
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling
Intervention Type
Other
Intervention Name(s)
questionaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy
Description
Number of reinfections with hepatitis C per 100 persons
Time Frame
up to two years
Secondary Outcome Measure Information:
Title
questionnaire to Identify risk factors associated with HCV reinfection
Time Frame
day 1
Title
questionaire to Identify risk factors associated with HCV reinfection
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, prof. dr.
Phone
+32 89 32 15 60
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Bielen, dr.
Phone
+32 89 32 15 60
Email
rob.bielen@zol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rob Bielen, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Free Clinic Antwerp
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catharina Mathëi, MD
Phone
+32 32 01 12 60
First Name & Middle Initial & Last Name & Degree
Maertens Griet, nurse
First Name & Middle Initial & Last Name & Degree
Catharina Mathëi, MD
Facility Name
ZNA Stuivenberg
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Bourgeois, dr.
Phone
+32 3 217 77 70
Email
stefan.bourgeois@zna.be
First Name & Middle Initial & Last Name & Degree
Stefan Bourgeois, dr.
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Mulkay, prof. dr.
Phone
0032 24115161
Email
Jean-Pierre_MULKAY@stpierre-bru.be
First Name & Middle Initial & Last Name & Degree
Sarah Vanderwaeren, nurse
Email
vanderwaeren.s@projetlama.be
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Mulkay, prof. dr.
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Busschots, dr.
Phone
+32 89 21 20 61
Email
dana.busschots@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Eefje Dercon, nurse
Phone
+32 89 21 20 61
Email
eefje.dercon@cadlimburg.be
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
First Name & Middle Initial & Last Name & Degree
Dana Busschots, drs.
First Name & Middle Initial & Last Name & Degree
Eefje Dercon, nurse
Facility Name
AZ Maria-Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Van Steenkiste, dr.
Phone
+32 9 246 71 00
Email
christophe.vansteenkiste@azmmsj.bee
First Name & Middle Initial & Last Name & Degree
Christophe Van Steenkiste, dr.
Facility Name
CAD Limburg
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Busschots, drs.
Phone
+32 89 21 20 61
Email
dana.busschots@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Eefje Dercon, nurse
Phone
+32 11 27 42 98
Email
eefje.dercon@cadlimburg.be
First Name & Middle Initial & Last Name & Degree
Rita Verrando, dr.
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Janssens, dr.
Phone
+32 11 33 76 00
Email
filip.janssens@jessazh.be
First Name & Middle Initial & Last Name & Degree
Filip Janssens, dr.
Facility Name
CHC Saint-Josephe, Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Bastens, prof. dr.
Phone
32 42 24 89 60
Email
boris.bastens@chc.be
First Name & Middle Initial & Last Name & Degree
Annick Deflandre, study nurse
First Name & Middle Initial & Last Name & Degree
Boris Bastens, prof. dr.
Facility Name
Sint-Trudo Ziekenhuis
City
Sint-Truiden
ZIP/Postal Code
3800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
luc Van Den Bergh, dr.
Phone
+32 11 69 96 00
Email
luc.vandenbergh@stzh.be
First Name & Middle Initial & Last Name & Degree
luc Van Den Bergh, dr.
Facility Name
AZ Vesalius
City
Tongeren
ZIP/Postal Code
3700
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Posen, dr.
Phone
+32 12 39 70 05
Email
annelies.posen@azvesalius.be
First Name & Middle Initial & Last Name & Degree
Annelies Posen, dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34641896
Citation
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.
Results Reference
derived

Learn more about this trial

HCV Reinfection After DAA Therapy in PWID in Belgium

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