Treatment as Prevention for Hepatitis C in Iceland

NCT ID: NCT02647879

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2031-05-31

Brief Summary

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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

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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

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatitis C infected

All patients diagnosed with hepatitis C in Iceland

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.

Exclusion Criteria

* Age under 18 years
* Inability to sign informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center of Addiction Medicine (SAA)

OTHER

Sponsor Role collaborator

Landspitali University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigurdur Olafsson, MD

Role: PRINCIPAL_INVESTIGATOR

Landspitali University Hospital

Locations

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Landspitali

Reykjavik, , Iceland

Site Status RECRUITING

Countries

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Iceland

Central Contacts

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Ragnheidur Fridriksdottir, B.Sc, MA

Role: CONTACT

+ 354 543 6096

Halla Arnardottir, B Sc

Role: CONTACT

+354 5435711

Facility Contacts

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Ragnheidur Fridriksdottir

Role: primary

Halla Arnardottir

Role: backup

References

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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.

Reference Type DERIVED
PMID: 35438144 (View on PubMed)

Olafsson 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.

Reference Type DERIVED
PMID: 34171267 (View on PubMed)

Olafsson 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.

Reference Type DERIVED
PMID: 29512219 (View on PubMed)

Other Identifiers

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LSH-15-003

Identifier Type: -

Identifier Source: org_study_id

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