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Само по покана Фаза 3 NCT05667493

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Спонсор: Ionis Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
Описание
This is a multicenter, open-label extension, Phase 3 study in up to approximately 1400 participants from the 682884-CS2 study. Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or until after eplontersen is approved and available in the site's country, whichever occurs first. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A.
Кой може да участва
Inclusion Criteria: 1. Satisfactory completion of Treatment Period and the End of Treatment Visit of the Index Study (ION-682884-CS2) OR diagnosis of ATTR-CM and satisfactory participation on ISIS 420915- CS101 study as judged by the Investigator and Sponsor. 2. Investigator is willing to treat the participant with open-label eplontersen. 3. Willingness to adhere to vitamin A supplementation per protocol. Exclusion Criteria: 1. Permanently discontinued study drug administration while participating in the Index Study (ION 682884-CS2) or IST (ISIS 420915-CS101 Study). 2. Have any new condition or worsening of an existing condition that in the opinion of the Investigator or Sponsor would make the participant unsuitable for enrolment, or which could interfere with the participant participating in or completing the study, including the need for treatment with medications disallowed in the Index Study.
Места на провеждане 17
Argentina (1)
Hospital Italiano de Buenos Aires
Buenos Aires
Австралия (1)
Advara HeartCare
Joondalup , Western Australia
Белгия (1)
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges
Бразилия (1)
Hospital Moinhos de Vento
Porto Alegre
Канада (1)
University of Calgary
Calgary , Alberta
Чехия (1)
Fakultní Nemocnice u sv. Anny v Brně
Brno
Дания (1)
Rigshospitalet
Copenhagen
Франция (1)
Hôpitaux Universitaires Henri Mondor
Créteil
Гърция (1)
General Hospital of Athens "Alexandra"
Athens
Израел (1)
Rambam Health Care Campus
Haifa
Италия (1)
Azienda Ospedaliero Universitaria Delle Marche
Ancona
Япония (1)
Kurume University Hospital
Kurume-Shi , Fukuoka
Полша (1)
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow
Испания (1)
Hospital Universitari Vall d'Hebrón
Barcelona
Швеция (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
Великобритания (1)
AES - Synexus - Scotland Clinical Research Centre
Bellshill , England
САЩ (1)
Mayo Clinic
Scottsdale , Arizona
Технически детайли
Статус
Само по покана
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.11.2022
Крайна дата
01.08.2029
Регистрационен номер
NCT05667493
Източник
anzctr
Запитване за медицински туризъм

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