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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) up to visit 39 (week 156)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) up to visit 39 (week 156) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Treatment Emergent Adverse Events

Secondary outcome measures

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 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,988 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

106 Previous Clinical Trials

139,746 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently open for enrollment?

"Information from clinicaltrials.gov reveals that this investigation is currently not open for enrollment. Despite being posted on 2/9/2024 and last updated on 2/7/2024, the trial has concluded recruitment. However, there are presently 264 alternative trials actively seeking participants."

Answered by AI

At how many distinct sites is the management of this study taking place?

"The ongoing recruitment for this study spans 23 research sites, including prominent locations such as Beverly Hills, Vancouver, and Toulouse Cedex 9. Opting for a site in close proximity to your residence is advisable to reduce travel obligations during participation."

Answered by AI

Is there an age restriction for potential participants under 30 years old in this clinical trial?

"As per the trial's entry requirements, individuals aged 18 to 85 are eligible to take part in this study."

Answered by AI

Has the drug NNC6019-0001 gained approval from the FDA?

"At Power, our assessment rates the safety of NNC6019-0001 as a 2 on the scale due to being in Phase 2. While there is some existing safety data, efficacy evidence is lacking at this stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260709.

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