Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-07-01
2022-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Blood sampling
Blood sampling
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.
Interventions
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Blood sampling
Blood sampling
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Jessa Hospital
OTHER
Algemeen Ziekenhuis Vesalius
OTHER
CAD Limburg
UNKNOWN
Sint-Trudo
UNKNOWN
Free Clinic Antwerp
UNKNOWN
Ziekenhuis Netwerk Antwerpen (ZNA)
OTHER
Clinique Saint Joseph, Liège
OTHER
Centre Hospitalier Universitaire Saint Pierre
OTHER
Algemeen Ziekenhuis Maria Middelares
OTHER
Hasselt University
OTHER
Responsible Party
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Geert Robaeys
Principal Investigator
Principal Investigators
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Geert Robaeys, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Rob Bielen, dr.
Role: STUDY_CHAIR
Hasselt University
Locations
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Free Clinic Antwerp
Antwerp, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
AZ Maria-Middelares
Ghent, , Belgium
CAD Limburg
Hasselt, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
CHC Saint-Josephe, Liège
Liège, , Belgium
Sint-Trudo Ziekenhuis
Sint-Truiden, , Belgium
AZ Vesalius
Tongeren, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Catharina Mathëi, MD
Role: primary
Maertens Griet, nurse
Role: backup
Annick Deflandre, study nurse
Role: backup
References
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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.
Other Identifiers
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18/0012U
Identifier Type: -
Identifier Source: org_study_id
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