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

ID do estudo: NCT06260709).

condição: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

status: Recrutamento

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).

intervenção: NNC6019-0001

resultados: https://clinicaltrials.gov/ct2/show/results/NCT06260709

Ultima atualização: 10 de março de 2024

data de início: 20 de fevereiro de 2024

conclusão estimada: 29 de fevereiro de 2028

Ultima atualização: 22 de fevereiro de 2024

fase de desenvolvimento: Fase 2

tamanho / inscrição: 80

desfechos primários:

• Number of Treatment Emergent Adverse Events
  Measured as events.
• From baseline (week 0) up to visit 39 (week 156)
  

resultados secundários:

• Change in 6-Minute Walk Test (6MWT)
  From baseline (week 0) to visit 28 (week 104)
• Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
  From baseline (week 0) to visit 28 (week 104)
• Change in Myocardial Extracellular Volume (ECV)
  From baseline (week 0) to visit 28 (week 104)
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
  From baseline (week 0) to visit 28 (week 104)
• Change in Troponin I
  From baseline (week 0) to visit 28 (week 104)
• Change in Global Longitudinal Strain (GLS) on Echocardiography
  From baseline (week 0) to visit 28 (week 104)

critério de inclusão:

critério de exclusão: Critérios:

A prior solid organ transplant.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

patrocinador: Novo Nordisk A / S

Contatos: Novo Nordisk, (+ 1) 866-867-7178, [email protegido]

investigadores: Clinical Transparency (dept. 2834),Novo Nordisk A/S

locais do centro de ensaios: United States,Canada,Czechia,France,Germany,Italy,Netherlands,Portugal,Spain

• Estados Unidos, Arizona
  Clínica Mayo Arizona
  
  
• Estados Unidos, Califórnia
  Cedars-Sinai Medical Center_Los Angeles
  
  
• Estados Unidos, Califórnia
  Clínica Stanford Hlth Cre-Boswell
  
  
• Estados Unidos, Flórida
  Clínica Mayo Jacksonville
  
  
• Estados Unidos, Illinois
  NW Univ-Bluhm Cardiovasc Inst
  
  
• Estados Unidos, Maryland
  Universidade de MD Schl de Med
  
  
• Estados Unidos, Minnesota
  Clínica Mayo Rochester
  
  
• Canadá, Alberta
  Universidade de Calgary_Cardiologia
  
  
• Canadá, Colúmbia Britânica
  Ctr para Inovação Cardiovascular
  
  
• czechia
  II. clínica interna VFN – Cardiologia e angiologia
  
  
• França
  Ap-Hp-Hospital Henri Mondor
  
  
• França
  Hospital Universitário de Toulouse-Hospital Rangueil-1
  
  
• Alemanha
  Clínica e Policlínica LMU Klinikum Munique 1
  
  
• Alemanha
  Hospital Universitário de Münster, Departamento de Cardiologia I
  
  
• Alemanha
  Hospital Universitário Würzburg AöR
  
  
• Alemanha
  Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
  
  
• Italy, PV
  Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
  
  
• Italy, Pi
  Fondazione CNR-Regione Toscana Gabriele Monasterio
  
  
• Nederland
  UMC Groningen
  
  
• Nederland
  Centro Médico Universitário de Utrecht
  
  
• Portugal
  Centro Hospitalar de Trás-os-Montes e Alto Douro
  
  
• Portugal
  Hospital da Senhora da Oliveira – Guimarães
  
  
• Espanha, Madri
  Hospital Universitário Puerta de Hierro Majadahonda