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MAGNITUDE: a Phase 3 Study of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)
765 patients around the world
Available in Argentina
This is a multinational, multicenter, double-blind, placebo-controlled study in
approximately 765 participants, who will be randomized to receive a single infusion of
either NTLA-2001 or placebo.
Intellia Therapeutics
1Research sites
765Patients around the world
This study is for people with
Rare diseases
Amyloidosis
Heart failure
Requirements for the patient
To 90 Years
All Gender
Medical requirements
- Documented diagnosis of ATTR amyloidosis with cardiomyopathy.Medical history of heart failure (HF).Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention.Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 1000 pg/mL or greater than or equal to 2000 pg/mL if participant has known atrial fibrillation.
- New York Heart Association (NYHA) Class IV HF.Polyneuropathy Disability score of IV confined to wheelchair or bed.Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.History of active malignancy within 3 years prior to screening.RNA silencer therapy patisiran, inotersen and/or eplontersen within 12 months prior to dosing. Any prior vutrisiran use is not allowed.Initiation of tafamidis within 6 months prior to study dosing.Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2.Liver failure.Uncontrolled blood pressure.Unable or unwilling to take vitamin A supplementation for the duration of the study.
Sites
Fundación Favaloro para la Docencia e Investigación Médica - CABA, Buenos Aires
Recruiting
SponsorIntellia Therapeutics
Conditions
AmyloidosisHeart failure
Requirements
To 90 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06128629
