Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275724
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-02-16
Brief Title:
Specified Drug-use Survey of Leqvio for sc Injection
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Specified Drug-use Survey of Leqvio for sc Injection Familial Hypercholesterolaemia or Hypercholesterolaemia CKJX839A11401
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
Detailed Description:
Uncontrolled central registration system multicenter special drug use-results surveillance
This is a prospective open-label multicenter single-arm observational study non-interventional study NIS conducted only in Japan
The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio whichever comes earlier
This is a prospective open-label multicenter single-arm observational study non-interventional study NIS conducted only in Japan
The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio whichever comes earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None