Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586062
Status:
AVAILABLE
Last Update Posted:
2023-10-05
First Post:
2020-10-06
Brief Title:
Sponsor Initiated Expanded Access Protocol Intermediate-Size Patient Population
Sponsor:
Kedrion SpA
Organization:
Kedrion SpA
Study Overview
Official Title:
Sponsor Initiated Expanded Access Protocol Intermediate-Size Patient Population
Status:
AVAILABLE
Status Verified Date:
2023-10
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:
The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure andor until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial
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?:
None