Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-28 @ 6:04 PM
Study NCT ID:
NCT04169061
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Sponsor:
Mallinckrodt
Organization:
Study Overview
Official Title:
A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
Status:
COMPLETED
Status Verified Date:
2021-07
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:
We will need about 36 participants for this study.
Volunteers might be able to participate if:
* they have bad noninfectious keratitis
* early treatments failed or were not well tolerated
Participants will be in the study for about 22 weeks:
* 4 weeks for tests to see if the study might be good for them
* 12 weeks of treatment with Acthar gel
* 4 weeks to wean off Acthar gel and follow-up with the doctor
Volunteers might be able to participate if:
* they have bad noninfectious keratitis
* early treatments failed or were not well tolerated
Participants will be in the study for about 22 weeks:
* 4 weeks for tests to see if the study might be good for them
* 12 weeks of treatment with Acthar gel
* 4 weeks to wean off Acthar gel and follow-up with the doctor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: