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Treatment as Prevention for Hepatitis C in Iceland (TraPHepC)

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ClinicalTrials.gov Identifier: NCT02647879
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
National Center of Addiction Medicine (SAA)
Information provided by (Responsible Party):
Landspitali University Hospital

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.

Condition or disease
Hepatitis C

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2031

Resource links provided by the National Library of Medicine


Group/Cohort
Hepatitis C infected
All patients diagnosed with hepatitis C in Iceland



Primary Outcome Measures :
  1. Incidence of transmission of HCV in Iceland [ Time Frame: Measured annually for up to 15 years ]

Secondary Outcome Measures :
  1. Incidence of cirrhosis and hepatocellular carcinoma in Iceland [ Time Frame: Measured annually for up to 15 years ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed with chronic HCV infection in Iceland
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647879


Contacts
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Contact: Ragnheidur Fridriksdottir, B.Sc, MA + 354 543 6096 ragnhefr@landspitali.is
Contact: Halla Arnardottir, B Sc +354 5435711 hallarn@landspitali.is

Locations
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Iceland
Landspitali Recruiting
Reykjavik, Iceland
Contact: Ragnheidur Fridriksdottir         
Contact: Halla Arnardottir         
Sponsors and Collaborators
Landspitali University Hospital
National Center of Addiction Medicine (SAA)
Investigators
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Principal Investigator: Sigurdur Olafsson, MD Landspitali University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Landspitali University Hospital
ClinicalTrials.gov Identifier: NCT02647879    
Other Study ID Numbers: LSH-15-003
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections