Меню
Идёт набор NCT02647879

Treatment as Prevention for Hepatitis C in Iceland

— Наблюдательное Hepatitis C

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hepatitis C. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Iceland
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Incidence of transmission of HCV in Iceland [Срок оценки: Measured annually for up to 15 years]
Вторичные конечные точки (3)
  • Incidence of cirrhosis and hepatocellular carcinoma in Iceland [Срок оценки: 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 [Срок оценки: Measured for up to 36 months]
  • Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR [Срок оценки: Measured for up to 36 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Iceland · 1 центр
  • Landspitali — Reykjavik

Публикации

  • 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(1 PMID 35438144
  • 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 Gas PMID 34171267
  • 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/jo PMID 29512219

Идентификаторы

NCT: NCT02647879 · LSH-15-003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗