Hepatitis COpportuni-CNCT04220645
Opportunstic Hepatitis C Virus Treatment
A study testing Opportunstic treatment in people with Hepatitis C and Substance Use Disorders, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. 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?
- Opportunstic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2019to 30 Jun 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
- Above 18 years of age
- HCV RNA positive
- Inpatient at participating ward
- Signed informed consent must be obtained and documented according to national and local regulations
Who cannot join
- Pregnancy or breastfeeding.
- In involuntarily health care.
- Ongoing treatment of hepatitis C.
- Current participation in another trial that might affect the current study.
- Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients
The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.
Read the detailed description
The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure.
We will use a stepped wedge design and include patients in 7 clusters
Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.
- Conditions
- Hepatitis C, Substance Use Disorders
- Being tested
- Opportunstic treatment, Standard of care
- 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.
Opportunstic treatmentOther
opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards
Standard of careOther
Referral at discharge
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge. Receives: Other: Standard of care |
| Opportunistic treatment | Experimental | Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards Receives: Other: Opportunstic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion
Proportion in each arm who have been dispensed the last 28 days package of HCV treatment
Measured: 12 weeks
Secondary outcomes (3)
Sustained virological response
HCV RNA undetetctable 12 weeks after end of treatment
Measured: 24 weeks
Reinfection
A HCV RNA strain not present at baseline is detected during or after treatment
Measured: Two years
End of treatment response
Proportion in each arm who have undetectable HCV RNA at the end of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic clinical trial. Cluster randomised with stepped wedge design
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Dalgard, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220645
- Sponsor's protocol ID
- 2019/128
- Acronym
- Opportuni-C
- Status last verified
- Dec 2022
- First submitted
- 1 Oct 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Midgard H, Malme KB, Pihl CM, Berg-Pedersen RM, Tanum L, Klundby I, Haug A, Tveter I, Bjornestad R, Olsen IC, Finbraten AK, Dalgard O. Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial. Clin Infect Dis. 2024 Mar 20;78(3):582-590. doi: 10.1093/cid/ciad711.
PubMed 37992203Midgard H, Finbraten AK, Malme KB, Berg-Pedersen RM, Tanum L, Olsen IC, Bjornestad R, Dalgard O. Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs. Trials. 2020 Jun 15;21(1):524. doi: 10.1186/s13063-020-04434-8.
PubMed 32539853
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04220645
- Acronym / sponsor ID
- Opportuni-C / 2019/128
- Conditions
- Hepatitis C, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jan 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 project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.
Detailed description
The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure.
We will use a stepped wedge design and include patients in 7 clusters
Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic clinical trial. Cluster randomised with stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careHospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge. |
| Opportunistic treatment | Experimental | Other: Opportunstic treatmentHospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 18 years of age
- HCV RNA positive
- Inpatient at participating ward
- Signed informed consent must be obtained and documented according to national and local regulations
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding.
- In involuntarily health care.
- Ongoing treatment of hepatitis C.
- Current participation in another trial that might affect the current study.
- Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
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 |
|---|---|---|
| Opportunstic treatmentopportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards | Other | Opportunistic treatment |
| Standard of careReferral at discharge | Other | Standard of care |
Primary outcome
Treatment completion
Time frame: 12 weeks
Proportion in each arm who have been dispensed the last 28 days package of HCV treatment
3 secondary outcomes
Sustained virological response
Time frame: 24 weeks
Reinfection
Time frame: Two years
End of treatment response
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Derived from this study: PubMed 37992203Midgard H, Malme KB, Pihl CM, Berg-Pedersen RM, Tanum L, Klundby I, Haug A, Tveter I, Bjornestad R, Olsen IC, Finbraten AK, Dalgard O. Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial. Clin Infect Dis. 2024 Mar 20;78(3):582-590. doi: 10.1093/cid/ciad711.
- Derived from this study: PubMed 32539853Midgard H, Finbraten AK, Malme KB, Berg-Pedersen RM, Tanum L, Olsen IC, Bjornestad R, Dalgard O. Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs. Trials. 2020 Jun 15;21(1):524. doi: 10.1186/s13063-020-04434-8.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opportunstic treatment in people with 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Dec 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment completion (time frame: 12 weeks). 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 NCT04220645, which also lists 2 linked publications.
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 8 Dec 2022.