Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Status: Active_not_recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.

• Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

Locations
United States
Arizona
Mayo Clinic Arizona
Phoenix
California
Cedars-Sinai Medical Center_Los Angeles
Los Angeles
Stanford Hlth Cre-Boswell Clin
Stanford
Florida
Mayo Clinic Jacksonville
Jacksonville
Illinois
NW Univ-Bluhm Cardiovasc Inst
Chicago
NW Univ-Bluhm Cardiovasc Inst
Evanston
Maryland
Univ of MD Schl of Med
Baltimore
Minnesota
Mayo Clinic Rochester
Rochester
Other Locations
Canada
University of Calgary_Cardiology
Calgary
Ctr for Cardiovascular Innovation
Vancouver
France
Ap-Hp-Hopital Henri Mondor
Créteil
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
Toulouse
Germany
UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie
Heidelberg
Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
Heidelberg
LMU Klinikum München Klinik und Poliklinik 1
München
Uniklinik Münster, Klinik für Kardiologie I
Münster
Universitätsklinikum Münster - Klinik für Kardiologie I
Münster
Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz
Würzburg
Universitatsklinikum Wurzburg AöR
Würzburg
Italy
Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
Pavia
Fondazione CNR-Regione Toscana Gabriele Monasterio
Pisa
Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare
Pisa
Japan
Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology
Fukuoka
Hiroshima University hospital, Cardiovascular Medicine
Hiroshima
Kumamoto University Hospital, Cardiovascular Medicine
Kumamoto-shi, Kumamoto
Shinshu University Hospital, Department of Neurology
Nagano
Nagasaki University Hospital, Cardiovascular Medicine
Nagasaki
Netherlands
UMC Groningen
Groningen
Universitair Medisch Centrum Utrecht
Utrecht
Portugal
Hospital da Senhora da Oliveira - Guimarães
Guimarães
Unidade Local de Saude do Alto Ave, E.P.E.
Guimarães
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Time Frame
Start Date: 2024-02-20
Completion Date: 2028-08-15
Participants
Target number of participants: 80
Treatments
Experimental: NNC6019-0001
Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov