Ignite Creation Date:
2025-12-18 @ 8:26 AM
Ignite Modification Date:
2025-12-23 @ 6:12 PM
Study NCT ID:
NCT03774615
Status:
None
Last Update Posted:
2020-04-21 00:00:00
First Post:
2018-12-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1)
Status:
None
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION-LVAD-1
Brief Summary:
This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.
Detailed Description:
None
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?: