ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-02-20
Study Completion:2028-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06260709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
  1. * A prior solid organ transplant.
  2. * 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.
  3. * 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.
  4. * Body weight greater than (\>) 120 kilograms (kg) (264.6 pounds \[lb\]) at screening.

Contacts and Locations

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Cedars-Sinai Medical Center_Los Angeles
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

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-20
Study Completion Date2028-08-15

Study Record Updates

Study Start Date2024-02-20
Study Completion Date2028-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Transthyretin Amyloid Cardiomyopathy (ATTR CM)