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NNC6019-0001 for Transthyretin Amyloid Cardiomyopathy
Phase 2
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). Dihydropyridine calcium channel blockers are allowed. Digoxin allowed only for management of atrial fibrillation with rapid ventricular response
Body weight greater than 120 kilograms (kg) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) up to visit 39 (week 156)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a medicine, NNC6019-0001, for people with heart disease caused by TTR amyloidosis. It will assess the long-term safety and effectiveness of the medicine
Who is the study for?
This trial is for people who have heart failure due to Transthyretin Amyloidosis and were part of a previous study on the medicine NNC6019-0001. Only those who completed the initial study can join this long-term research to further assess safety and effectiveness.
What is being tested?
The trial is testing NNC6019-0001, focusing on its long-term safety and ability to alleviate symptoms of heart disease caused by TTR amyloidosis. Participants will receive NNC6019-0001 for up to 157 weeks, regardless of their prior treatment group.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions over the course of three years as they continue treatment with NNC6019-0001.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking specific heart medications, but not those that mainly affect blood pressure.
Select...
My body weight is over 120 kg.
Select...
I have had a solid organ transplant in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) up to visit 39 (week 156)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) up to visit 39 (week 156)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Treatment Emergent Adverse Events
Secondary study objectives
Change in 6-Minute Walk Test (6MWT)
Change in Global Longitudinal Strain (GLS) on Echocardiography
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NNC6019-0001Experimental Treatment1 Intervention
Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,646,427 Total Patients Enrolled
1 Trials studying Transthyretin Amyloid Cardiomyopathy
120 Patients Enrolled for Transthyretin Amyloid Cardiomyopathy
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,833 Total Patients Enrolled