Hepatitis CTraPHepCNCT02647879
Treatment as Prevention for Hepatitis C in Iceland
An observational study of Hepatitis C, run by Landspitali University Hospital at 1 site in Iceland.
Trial summary
The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 1,000 participants
- Where
- 1 siteIceland
- Study dates
- Jan 2016to May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients diagnosed with chronic HCV infection in Iceland
Who may be able to join
- HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.
Who cannot join
- Age under 18 years
- Inability to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali
Reykjavik
Ragnheidur Fridriksdottir
Halla Arnardottir
About this study
Official title: Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment
The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.
Read the detailed description
In Iceland, a nationwide effort is planned where all patients with HCV infection will be offered treatment using direct acting antiviral agents. The aim of the initiative, besides offering cure to patients, is to substantially reduce domestic transmission of HCV and thereby lower the incidence. Ultimately, with these intense efforts the long-term complications of chronic HCV infection could potentially be nearly eliminated. In Iceland, there is mandatory reporting of all new cases of hepatitis C to the State Epidemiologist.
In the study, short term and long term outcomes of this initiative will be investigated. In an initial treatment phase which will last for up to three years, all patients diagnosed with hepatitis C in Iceland will be offered treatment with direct acting antiviral agents. Virological response rate and compliance will be monitored. Long term, the incidence of HCV infection acquired in Iceland will be monitored for up to 15 years, and the incidence rates of cirrhosis and hepatocellular carcinoma due to HCV will be monitored for up to 15 years.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
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 |
|---|---|---|
| Hepatitis C infected | All patients diagnosed with hepatitis C in Iceland |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transmission of HCV in Iceland
Measured: Measured annually for up to 15 years
Secondary outcomes (3)
Incidence of cirrhosis and hepatocellular carcinoma in Iceland
Measured: Measured annually for up to 15 years
Sustained virological response rate (SVR) to treatment with antiviral agents as measured by negative HCV RNA 12 weeks post treatment
Measured: Measured for up to 36 months
Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR
Measured: Measured for up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Addiction Medicine (SAA)
- Responsible party
- Sponsor
- Investigators
- Sigurdur Olafsson, MD, Principal investigator, Landspitali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647879
- Sponsor's protocol ID
- LSH-15-003
- Acronym
- TraPHepC
- Status last verified
- Sep 2020
- First submitted
- 30 Dec 2015
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Johannesson JM, Fridriksdottir RH, Love TJ, Runarsdottir V, Hansdottir I, Love A, Thordardottir M, Hernandez UB, Olafsson S, Gottfredsson M; Treatment as Prevention for Hepatitis C (TraP Hep C) group. High Rate of Hepatitis C Virus Reinfection Among Recently Injecting Drug Users: Results From the TraP Hep C Program-A Prospective Nationwide, Population-Based Study. Clin Infect Dis. 2022 Nov 14;75(10):1732-1739. doi: 10.1093/cid/ciac272.
PubMed 35438144Olafsson S, Fridriksdottir RH, Love TJ, Tyrfingsson T, Runarsdottir V, Hansdottir I, Bergmann OM, Bjornsson ES, Johannsson B, Sigurdardottir B, Love A, Baldvinsdottir GE, Hernandez UB, Gudnason T, Heimisdottir M, Hellard M, Gottfredsson M. Cascade of care during the first 36 months of the treatment as prevention for hepatitis C (TraP HepC) programme in Iceland: a population-based study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):628-637. doi: 10.1016/S2468-1253(21)00137-0. Epub 2021 Jun 23.
PubMed 34171267Olafsson S, Tyrfingsson T, Runarsdottir V, Bergmann OM, Hansdottir I, Bjornsson ES, Johannsson B, Sigurdardottir B, Fridriksdottir RH, Love A, Hellard M, Love TJ, Gudnason T, Heimisdottir M, Gottfredsson M. Treatment as Prevention for Hepatitis C (TraP Hep C) - a nationwide elimination programme in Iceland using direct-acting antiviral agents. J Intern Med. 2018 May;283(5):500-507. doi: 10.1111/joim.12740. Epub 2018 Mar 7.
PubMed 29512219
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment
- ClinicalTrials.gov ID
- NCT02647879
- Acronym / sponsor ID
- TraPHepC / LSH-15-003
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- National Center of Addiction Medicine (SAA)
- Study start
- Jan 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- 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 main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.
Detailed description
In Iceland, a nationwide effort is planned where all patients with HCV infection will be offered treatment using direct acting antiviral agents. The aim of the initiative, besides offering cure to patients, is to substantially reduce domestic transmission of HCV and thereby lower the incidence. Ultimately, with these intense efforts the long-term complications of chronic HCV infection could potentially be nearly eliminated. In Iceland, there is mandatory reporting of all new cases of hepatitis C to the State Epidemiologist.
In the study, short term and long term outcomes of this initiative will be investigated. In an initial treatment phase which will last for up to three years, all patients diagnosed with hepatitis C in Iceland will be offered treatment with direct acting antiviral agents. Virological response rate and compliance will be monitored. Long term, the incidence of HCV infection acquired in Iceland will be monitored for up to 15 years, and the incidence rates of cirrhosis and hepatocellular carcinoma due to HCV will be monitored for up to 15 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C infected | – | –All patients diagnosed with hepatitis C in Iceland |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with chronic HCV infection in Iceland
Key inclusion criteria (1 listed)
- HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.
Key exclusion criteria (2 listed)
- Age under 18 years
- Inability to sign informed consent.
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
Incidence of transmission of HCV in Iceland
Time frame: Measured annually for up to 15 years
3 secondary outcomes
Incidence of cirrhosis and hepatocellular carcinoma in Iceland
Time frame: Measured annually for up to 15 years
Sustained virological response rate (SVR) to treatment with antiviral agents as measured by negative HCV RNA 12 weeks post treatment
Time frame: Measured for up to 36 months
Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR
Time frame: Measured for up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Derived from this study: PubMed 35438144Johannesson JM, Fridriksdottir RH, Love TJ, Runarsdottir V, Hansdottir I, Love A, Thordardottir M, Hernandez UB, Olafsson S, Gottfredsson M; Treatment as Prevention for Hepatitis C (TraP Hep C) group. High Rate of Hepatitis C Virus Reinfection Among Recently Injecting Drug Users: Results From the TraP Hep C Program-A Prospective Nationwide, Population-Based Study. Clin Infect Dis. 2022 Nov 14;75(10):1732-1739. doi: 10.1093/cid/ciac272.
- Derived from this study: PubMed 34171267Olafsson S, Fridriksdottir RH, Love TJ, Tyrfingsson T, Runarsdottir V, Hansdottir I, Bergmann OM, Bjornsson ES, Johannsson B, Sigurdardottir B, Love A, Baldvinsdottir GE, Hernandez UB, Gudnason T, Heimisdottir M, Hellard M, Gottfredsson M. Cascade of care during the first 36 months of the treatment as prevention for hepatitis C (TraP HepC) programme in Iceland: a population-based study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):628-637. doi: 10.1016/S2468-1253(21)00137-0. Epub 2021 Jun 23.
- Derived from this study: PubMed 29512219Olafsson S, Tyrfingsson T, Runarsdottir V, Bergmann OM, Hansdottir I, Bjornsson ES, Johannsson B, Sigurdardottir B, Fridriksdottir RH, Love A, Hellard M, Love TJ, Gudnason T, Heimisdottir M, Gottfredsson M. Treatment as Prevention for Hepatitis C (TraP Hep C) - a nationwide elimination programme in Iceland using direct-acting antiviral agents. J Intern Med. 2018 May;283(5):500-507. doi: 10.1111/joim.12740. Epub 2018 Mar 7.
- Individual participant dataSharing planned: Undecided
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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.
Sigurdur Olafsson, MD principal investigator
Landspitali University Hospital
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, run by Landspitali University Hospital at 1 site in Iceland.
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 2 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: looking for participants now, as of the sponsor's last update on 25 Sep 2020. 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 Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ragnheidur Fridriksdottir, B.Sc, MA (+ 354 543 6096, ragnhefr@landspitali.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of transmission of HCV in Iceland (time frame: Measured annually for up to 15 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 NCT02647879, which also lists 3 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 25 Sep 2020.