Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260709
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-07
Brief Title:
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
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy ATTR CM
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 months3 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1284-5820 | OTHER | World Health Organization WHO | None |
| 2022-502605-15-00 | OTHER | None | None |