Hepatitis CPrindsenNCT04063839
HCV Treatment in a Low-threshold Clinic
An observational study of Hepatitis C and Substance Use Disorders, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Substance Use Disorders
- What is being tested?
- Elbasvir / Grazoprevir Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Dec 2022
- 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: Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)
Who may be able to join
- HCV RNA positive Attending the low-threshold HCV clinic in Oslo
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
AkershusUH
Lørenskog, Select A State Or Province, 0278
Olav Dalgard, MD PhD, 92616800, odalgard@medisin.uio.no
Kjersti Ulstein, MD PhD, 41226162 ext. 0047, kjersti.ulstein@vel.oslo.kommune.no
About this study
Official title: Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
Read the detailed description
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo
The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f
The secondary aims are to:
- Evaluate adherence to DAA treatment (Work Package 1)
- Identify factors associated with SVR and adherence (Work Package 1)
- Characterize reinfection using next generation sequencing (Work Package 2)
- Identify factors associated with reinfection (Work Package 2)
- Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
- Identify factors associated with changes in risk behaviours (Work Package 2)
The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.
The study will include 300 patients and are close to achieving that aim the summer of 2019
- Conditions
- Hepatitis C, Substance Use Disorders
- Being tested
- Elbasvir / Grazoprevir Oral Tablet
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir / Grazoprevir Oral TabletDrug
Also called sofosbuvir, ledipasvir
HCV treatment according to Norwegian guidelines
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
HCV RNA undetectable 12 weeks post treatment
Measured: 12 weeks
Reinfection
HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study startJan 2015
- Primary completion31 Oct 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Dalgard, University Hospital, Akershus
- Investigators
- Olav Dalgard, MD PhD, Study chair, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063839
- Sponsor's protocol ID
- 17_120
- Acronym
- Prindsen
- Status last verified
- Aug 2019
- First submitted
- 27 Jun 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: depends on patient privacy decission
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection
- ClinicalTrials.gov ID
- NCT04063839
- Acronym / sponsor ID
- Prindsen / 17_120
- Conditions
- Hepatitis C, Substance Use Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Aug 2019 (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.
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
Detailed description
This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years
Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo
The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f
The secondary aims are to:
- Evaluate adherence to DAA treatment (Work Package 1)
- Identify factors associated with SVR and adherence (Work Package 1)
- Characterize reinfection using next generation sequencing (Work Package 2)
- Identify factors associated with reinfection (Work Package 2)
- Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
- Identify factors associated with changes in risk behaviours (Work Package 2)
The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.
The study will include 300 patients and are close to achieving that aim the summer of 2019
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)
Key inclusion criteria (1 listed)
- HCV RNA positive Attending the low-threshold HCV clinic in Oslo
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Elbasvir / Grazoprevir Oral TabletAlso: sofosbuvir, ledipasvirHCV treatment according to Norwegian guidelines | Drug | – |
Primary outcome
Sustained virological response
Time frame: 12 weeks
HCV RNA undetectable 12 weeks post treatment
Reinfection
Time frame: 2 years
HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Undecided. depends on patient privacy decission
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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.
Olav Dalgard, MD PhD study chair
University Hospital, Akershus
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 and Substance Use Disorders, run by University Hospital, Akershus at 1 site in Norway.
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 1 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 21 Aug 2019. 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 Norway. 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 Olav Dalgard, MD PhD (92616800 ext. 47, odalgard@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.