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By invitation only Phase 3 NCT05667493

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

Phase 3 – large-scale trial before approval
Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)

Sponsor: Ionis Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.
Description
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.
Who can participate
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.
Locations 17
Argentina (1)
Hospital Italiano de Buenos Aires
Buenos Aires
Australia (1)
Advara HeartCare
Joondalup , Western Australia
Belgium (1)
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges
Brazil (1)
Hospital Moinhos de Vento
Porto Alegre
Canada (1)
University of Calgary
Calgary , Alberta
Czech Republic (1)
Fakultní Nemocnice u sv. Anny v Brně
Brno
Denmark (1)
Rigshospitalet
Copenhagen
France (1)
Hôpitaux Universitaires Henri Mondor
Créteil
Greece (1)
General Hospital of Athens "Alexandra"
Athens
Israel (1)
Rambam Health Care Campus
Haifa
Italy (1)
Azienda Ospedaliero Universitaria Delle Marche
Ancona
Japan (1)
Kurume University Hospital
Kurume-Shi , Fukuoka
Poland (1)
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow
Spain (1)
Hospital Universitari Vall d'Hebrón
Barcelona
Sweden (1)
Sahlgrenska Universitetssjukhuset
Gothenburg
United Kingdom (1)
AES - Synexus - Scotland Clinical Research Centre
Bellshill , England
United States (1)
Mayo Clinic
Scottsdale , Arizona
Technical details
Status
By invitation only
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.11.2022
Completion date
01.08.2029
Registry ID
NCT05667493
Source
anzctr
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