Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-03 @ 2:28 AM
Study NCT ID:
NCT02973620
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-05-16
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
Sponsor:
Tenax Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: