Hepatitis C, ChronicHepC:CACNCT05401136
Evaluating the Chain of Addiction Care (CAC)
An observational study of Hepatitis C, Chronic and Substance Use Disorders, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Substance Use Disorders
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2020to 1 Dec 2023
- Phase
- Observational
- 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
Study population: PWID of 18 years or older who visit the participating addiction care centre
Who may be able to join
- Aged 18 years or older
- Able and willing to give informed consent
- Currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws.
- Visit the participating addiction care centre at least once during the study period
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Daan Von Den Hoff, MD, +31625678779, daan.vondenhoff@radboudumc.nl
About this study
Official title: Evaluating the Hepatitis C Chain of Addiction Care Pathway for People Who Inject(ed) Drugs in Addiction Care
The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.
Read the detailed description
People who (have) inject(ed) drugs (PWID) are at high risk for hepatitis C infection. Establishing adequate linkage to care in this population can be a challenge. Many of these patients receive opioid substitution, hepatitis C treatment possibly influences pharmacokinetics of those substitutes. This protocol describes a study on hepatitis C in people who (have) inject(ed) drugs (PWID), consisting of two substudies. 1) An exploratory, observational study in which we evaluate the decentralised hepatitis C care pathway in addiction care centres. 2) An observational pharmacokinetic study in hepatitis C patients on opioid substitution therapy (OST) embedded within the first study.
Rationale: 1) Many PWIDs are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis C treatment. Decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. This practice however has not yet been evaluated in the Netherlands. 2) In the Netherlands the PWID population is often treated for opioid addiction by opioid substitution therapy (OST) with methadone (MET) or buprenorphine (BUP). There is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. Consequently, we hypothesize that HCV treatment results in reduced liver inflammation and a decrease in MET and/or BUP levels, which is clinically relevant in the PWID/OST population.
Objective: 1) to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. 2. to measure the impact of hepatitis C clearance on MET (+metabolites) and BUP (+metabolites) levels and craving in patients on OST.
Study design: This is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.
- Conditions
- Hepatitis C, Chronic, Substance Use Disorders
- Medical subject headings
- Hepatitis C, Chronic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Consecutive people who use drugs and visit the addiction care centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV prevalence (both anti-HCV and HCV RNA).
Participants are invited to undergo viral hepatitis screening (standard care)
Measured: At screening (week 0)
Treatment acceptance rate.
Participants with chronic HCV infection are invited to be treated (standard care)
Measured: After evaluation (~week 3)
Sustained virologic response
Participants who were treated and were 'cured' (standard care)
Measured: 12 weeks after treatment (~week 30)
Secondary outcomes (5)
Acceptance rate of on-site testing.
Number of participants that engage in testing
Measured: through study completion, an average of 1 year
Re-infection rate.
Patients re-infected after successful treatment
Measured: through study completion, an average of 1 year
Mean decrease in MET and BUP trough levels
Difference in concentration of methadone or buprenorphine before and after treatment.
Measured: through study completion, an average of 1 year
Change in dosage of MET and BUP during follow-up
Physician initiated dosage change before compared to after treatment of hepatitis C
Measured: through study completion, an average of 1 year
Patient reported drug use
Drug use during study timeframe
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Mar 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (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, ChronicStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401136
- Sponsor's protocol ID
- 2019-5939
- Acronym
- HepC:CAC
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Von den Hoff DW, Berden FAC, Drenth JPH, Schellekens AFA; HepNed, NISPA. Implementation of a decentralized hepatitis C care pathway for people who use drugs in Dutch addiction care. Study protocol for the Hepatitis C: chain of addiction care (CAC) project. Addict Sci Clin Pract. 2022 Nov 30;17(1):67. doi: 10.1186/s13722-022-00350-1.
PubMed 36451175
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Hepatitis C Chain of Addiction Care Pathway for People Who Inject(ed) Drugs in Addiction Care
- ClinicalTrials.gov ID
- NCT05401136
- Acronym / sponsor ID
- HepC:CAC / 2019-5939
- Conditions
- Hepatitis C, Chronic, Substance Use Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- AbbVie, Gilead Sciences
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Jun 2022 (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 investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.
Detailed description
People who (have) inject(ed) drugs (PWID) are at high risk for hepatitis C infection. Establishing adequate linkage to care in this population can be a challenge. Many of these patients receive opioid substitution, hepatitis C treatment possibly influences pharmacokinetics of those substitutes. This protocol describes a study on hepatitis C in people who (have) inject(ed) drugs (PWID), consisting of two substudies. 1) An exploratory, observational study in which we evaluate the decentralised hepatitis C care pathway in addiction care centres. 2) An observational pharmacokinetic study in hepatitis C patients on opioid substitution therapy (OST) embedded within the first study.
Rationale: 1) Many PWIDs are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis C treatment. Decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. This practice however has not yet been evaluated in the Netherlands. 2) In the Netherlands the PWID population is often treated for opioid addiction by opioid substitution therapy (OST) with methadone (MET) or buprenorphine (BUP). There is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. Consequently, we hypothesize that HCV treatment results in reduced liver inflammation and a decrease in MET and/or BUP levels, which is clinically relevant in the PWID/OST population.
Objective: 1) to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. 2. to measure the impact of hepatitis C clearance on MET (+metabolites) and BUP (+metabolites) levels and craving in patients on OST.
Study design: This is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Consecutive people who use drugs and visit the addiction care centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PWID of 18 years or older who visit the participating addiction care centre
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Able and willing to give informed consent
- Currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws.
- Visit the participating addiction care centre at least once during the study period
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HCV prevalence (both anti-HCV and HCV RNA).
Time frame: At screening (week 0)
Participants are invited to undergo viral hepatitis screening (standard care)
Treatment acceptance rate.
Time frame: After evaluation (~week 3)
Participants with chronic HCV infection are invited to be treated (standard care)
Sustained virologic response
Time frame: 12 weeks after treatment (~week 30)
Participants who were treated and were 'cured' (standard care)
5 secondary outcomes
Acceptance rate of on-site testing.
Time frame: through study completion, an average of 1 year
Re-infection rate.
Time frame: through study completion, an average of 1 year
Mean decrease in MET and BUP trough levels
Time frame: through study completion, an average of 1 year
Change in dosage of MET and BUP during follow-up
Time frame: through study completion, an average of 1 year
Patient reported drug use
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 36451175Von den Hoff DW, Berden FAC, Drenth JPH, Schellekens AFA; HepNed, NISPA. Implementation of a decentralized hepatitis C care pathway for people who use drugs in Dutch addiction care. Study protocol for the Hepatitis C: chain of addiction care (CAC) project. Addict Sci Clin Pract. 2022 Nov 30;17(1):67. doi: 10.1186/s13722-022-00350-1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Substance Use Disorders, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Daan Von den Hoff, M.D. (+31625678779, daan.vondenhoff@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV prevalence (both anti-HCV and HCV RNA). (time frame: At screening (week 0)). The study lists 3 primary outcomes in all. 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 NCT05401136, 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 2 Jun 2022.