NCT02647879

Brief 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 chronic HCV infection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2016May 2031

First Submitted

Initial submission to the registry

December 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Expected
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

5.9 years

First QC Date

December 30, 2015

Last Update Submit

September 24, 2020

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Incidence of transmission of HCV in Iceland

    Measured annually for up to 15 years

Secondary Outcomes (3)

  • Incidence of cirrhosis and hepatocellular carcinoma in Iceland

    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 for up to 36 months

  • Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR

    Measured for up to 36 months

Study Arms (1)

Hepatitis C infected

All patients diagnosed with hepatitis C in Iceland

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with chronic HCV infection in Iceland

You may qualify if:

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

You may not qualify if:

  • Age under 18 years
  • Inability to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Landspitali

Reykjavik, Iceland

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35438144DERIVED

  • 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.

    PMID: 34171267DERIVED

  • 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.

    PMID: 29512219DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Sigurdur Olafsson, MD

    Landspitali University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ragnheidur Fridriksdottir, B.Sc, MA

CONTACT

+ 354 543 6096ragnhefr@landspitali.is

Halla Arnardottir, B Sc

CONTACT

+354 5435711hallarn@landspitali.is

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion (Estimated)

May 1, 2031

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

IC(1)