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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502605-15-00 | Other Identifier | European Medical Agency (EMA) | |
| U1111-1284-5820 | Other Identifier | World Health Organization (WHO) | |
| jRCT2071240078 | Registry Identifier | JRCT |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC6019-0001 | Experimental | Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC6019-0001 | Drug | Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events | Measured as events. | From baseline (week 0) up to visit 39 (week 156) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6-Minute Walk Test (6MWT) | Measured in meters. | From baseline (week 0) to visit 28 (week 104) |
| Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) | Measured in percentage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Cedars-Sinai Medical Center_Los Angeles |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to visit 28 (week 104) |
| Change in Myocardial Extracellular Volume (ECV) | Measured in percentage-points. | From baseline (week 0) to visit 28 (week 104) |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Measured in score on a scale. | From baseline (week 0) to visit 28 (week 104) |
| Change in Troponin I | Measured in nanogram per milliliter (ng/mL). | From baseline (week 0) to visit 28 (week 104) |
| Change in Global Longitudinal Strain (GLS) on Echocardiography | Measured in percentage-points. | From baseline (week 0) to visit 28 (week 104) |
| Los Angeles |
| California |
| 90048 |
| United States |
| Stanford Hlth Cre-Boswell Clin | Stanford | California | 94305 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| NW Univ-Bluhm Cardiovasc Inst | Chicago | Illinois | 60611 | United States |
| NW Univ-Bluhm Cardiovasc Inst | Evanston | Illinois | 60208 | United States |
| Univ of MD Schl of Med | Baltimore | Maryland | 21201 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University of Calgary_Cardiology | Calgary | Alberta | T2N 4Z6 | Canada |
| Ctr for Cardiovascular Innovation | Vancouver | British Columbia | V5Z 1M9 | Canada |
| II. interni klinika VFN - Kardiologie a angiologie | Prague | 12808 | Czechia |
| Ap-Hp-Hopital Henri Mondor | Créteil | 94000 | France |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 | Toulouse | 31059 | France |
| UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie | Heidelberg | 69120 | Germany |
| Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie | Heidelberg | 69120 | Germany |
| LMU Klinikum München Klinik und Poliklinik 1 | München | 81377 | Germany |
| Uniklinik Münster, Klinik für Kardiologie I | Münster | 48149 | Germany |
| Universitätsklinikum Münster - Klinik für Kardiologie I | Münster | 48149 | Germany |
| Universitatsklinikum Wurzburg AöR | Würzburg | 97078 | Germany |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz | Würzburg | 97078 | Germany |
| Fondazione CNR-Regione Toscana Gabriele Monasterio | Pisa | Pi | 56124 | Italy |
| Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare | Pisa | Pi | 56124 | Italy |
| Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo | Pavia | PV | 27100 | Italy |
| Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology | Fukuoka | 807-8556 | Japan |
| Hiroshima University hospital, Cardiovascular Medicine | Hiroshima | 734-8551 | Japan |
| Kumamoto University Hospital, Cardiovascular Medicine | Kumamoto-shi, Kumamoto | 860-8556 | Japan |
| Shinshu University Hospital, Department of Neurology | Nagano | 390-8621 | Japan |
| Nagasaki University Hospital, Cardiovascular Medicine | Nagasaki | 852-8501 | Japan |
| Okayama University Hospital_Cardiovascular Medicine | Okayama-shi, Okayama | 700-8558 | Japan |
| UMC Groningen | Groningen | 9713 GZ | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Hospital da Senhora da Oliveira - Guimarães | Guimarães | 4835-044 | Portugal |
| Unidade Local de Saude do Alto Ave, E.P.E. | Guimarães | 4835-044 | Portugal |
| Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. | Vila Real | 5000-508 | Portugal |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |