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A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis
Sponsor: Novo Nordisk A/S
Summary
This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).
Official title: Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-02-20
Completion Date
2028-08-15
Last Updated
2025-11-25
Healthy Volunteers
No
Interventions
NNC6019-0001
Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.
Locations (35)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Cedars-Sinai Medical Center_Los Angeles
Los Angeles, California, United States
Stanford Hlth Cre-Boswell Clin
Stanford, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
NW Univ-Bluhm Cardiovasc Inst
Chicago, Illinois, United States
NW Univ-Bluhm Cardiovasc Inst
Evanston, Illinois, United States
Univ of MD Schl of Med
Baltimore, Maryland, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Calgary_Cardiology
Calgary, Alberta, Canada
Ctr for Cardiovascular Innovation
Vancouver, British Columbia, Canada
II. interni klinika VFN - Kardiologie a angiologie
Prague, Czechia
Ap-Hp-Hopital Henri Mondor
Créteil, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
Toulouse, France
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
Heidelberg, Germany
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
Heidelberg, Germany
LMU Klinikum München Klinik und Poliklinik 1
München, Germany
Uniklinik Münster, Klinik für Kardiologie I
Münster, Germany
Universitätsklinikum Münster - Klinik für Kardiologie I
Münster, Germany
Universitatsklinikum Wurzburg AöR
Würzburg, Germany
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
Würzburg, Germany
Fondazione CNR-Regione Toscana Gabriele Monasterio
Pisa, Pi, Italy
Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare
Pisa, Pi, Italy
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
Fukuoka, Japan
Hiroshima University hospital, Cardiovascular Medicine
Hiroshima, Japan
Kumamoto University Hospital, Cardiovascular Medicine
Kumamoto-shi, Kumamoto, Japan
Shinshu University Hospital, Department of Neurology
Nagano, Japan
Nagasaki University Hospital, Cardiovascular Medicine
Nagasaki, Japan
Okayama University Hospital_Cardiovascular Medicine
Okayama-shi, Okayama, Japan
UMC Groningen
Groningen, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital da Senhora da Oliveira - Guimarães
Guimarães, Portugal
Unidade Local de Saude do Alto Ave, E.P.E.
Guimarães, Portugal
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Vila Real, Portugal
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain