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NCT Number: NCT02647879

Treatment as Prevention for Hepatitis C in Iceland

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Landspitali

Reykjavik, Iceland

Location status: Recruiting

Location contact

Halla Arnardottir

CONTACT

Ragnheidur Fridriksdottir

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of transmission of HCV in Iceland

    Time frame: Measured annually for up to 15 years

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Halla Arnardottir, B Sc

CONTACT

[email protected]

+354 5435711

Ragnheidur Fridriksdottir, B.Sc, MA

CONTACT

[email protected]

+ 354 543 6096

Sponsors and collaborators

Lead sponsor

Landspitali University Hospital

Other

Collaborators

  • National Center of Addiction Medicine (SAA)

Registry information

Official study title

Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment

Acronym: TraPHepC

Important dates

Study start
2016
Primary completion
2021
Study completion
2031
First posted
Jan 6, 2016
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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