Hepatitis C Virus Infection, Response to Therapy ofREINF_HCVNCT04251572
HCV Reinfection After DAA Therapy in PWID in Belgium
A study testing Blood sampling and questionaires in people with Hepatitis C Virus Infection, Response to Therapy of and Drug Use, run by Hasselt University at 10 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of, Drug Use
- What is being tested?
- Blood sampling and questionaires
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesBelgium
- Study dates
- 1 Jul 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not fulfilling the inclusion criteria.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites, 10 recruiting
- Recruiting
Free Clinic Antwerp
Antwerp, 2000
Catharina Mathëi, MD, +32 32 01 12 60
Maertens Griet, nurse
- Recruiting
ZNA Stuivenberg
Antwerp, 2000
Stefan Bourgeois, dr., +32 3 217 77 70, stefan.bourgeois@zna.be
Stefan Bourgeois, dr.
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Jean-Pierre Mulkay, prof. dr., 0032 24115161, Jean-Pierre_MULKAY@stpierre-bru.be
Sarah Vanderwaeren, nurse, vanderwaeren.s@projetlama.be
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Dana Busschots, dr., +32 89 21 20 61, dana.busschots@uhasselt.be
Eefje Dercon, nurse, +32 89 21 20 61, eefje.dercon@cadlimburg.be
- Recruiting
AZ Maria-Middelares
Ghent, 9000
Christophe Van Steenkiste, dr., +32 9 246 71 00, christophe.vansteenkiste@azmmsj.bee
Christophe Van Steenkiste, dr.
- Recruiting
CAD Limburg
Hasselt, 3500
Dana Busschots, drs., +32 89 21 20 61, dana.busschots@uhasselt.be
Eefje Dercon, nurse, +32 11 27 42 98, eefje.dercon@cadlimburg.be
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Filip Janssens, dr., +32 11 33 76 00, filip.janssens@jessazh.be
Filip Janssens, dr.
- Recruiting
CHC Saint-Josephe, Liège
Liège, 4000
Boris Bastens, prof. dr., 32 42 24 89 60, boris.bastens@chc.be
Annick Deflandre, study nurse
- Recruiting
Sint-Trudo Ziekenhuis
Sint-Truiden, 3800
luc Van Den Bergh, dr., +32 11 69 96 00, luc.vandenbergh@stzh.be
luc Van Den Bergh, dr.
- Recruiting
AZ Vesalius
Tongeren, 3700
Annelies Posen, dr., +32 12 39 70 05, annelies.posen@azvesalius.be
Annelies Posen, dr.
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood sampling, questionaires
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sampling; Other: questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to two years
Secondary outcomes (2)
questionnaire to Identify risk factors associated with HCV reinfection
Measured: day 1
questionaire to Identify risk factors associated with HCV reinfection
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jul 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
- Investigators
- Geert Robaeys, prof. dr., Principal investigator, Hasselt UniversityRob Bielen, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251572
- Sponsor's protocol ID
- 18/0012U
- Acronym
- REINF_HCV
- Status last verified
- Aug 2021
- First submitted
- 30 May 2018
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34641896
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Reinfection After Successful Directly Acting Antiviral Treatment: A Belgian Interventional Multicenter Study
- ClinicalTrials.gov ID
- NCT04251572
- Acronym / sponsor ID
- REINF_HCV / 18/0012U
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- 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
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV reinfection after DAA therapy in PWID | Experimental | Other: Blood sampling, Other: questionairesHepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not fulfilling the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling | Other | HCV reinfection after DAA therapy in PWID |
| questionairesIncluded 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. | Other | HCV reinfection after DAA therapy in PWID |
Primary outcome
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
2 secondary outcomes
questionnaire to Identify risk factors associated with HCV reinfection
Time frame: day 1
questionaire to Identify risk factors associated with HCV reinfection
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 34641896Busschots 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.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
Hepatitis C, Transmission, Intravenous Drug Abuser
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert Robaeys, prof. dr. principal investigator
Hasselt University
Rob Bielen, dr. study chair
Hasselt University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling and questionaires in people with Hepatitis C Virus Infection, Response to Therapy of and Drug Use, run by Hasselt University at 10 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geert Robaeys, prof. dr. (+32 89 32 15 60, geert.robaeys@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy (time frame: up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.