Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-30 @ 3:38 PM
Study NCT ID:
NCT01416493
Status:
COMPLETED
Last Update Posted:
2015-03-10
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bovine Intestinal Alkaline Phosphatase (bIAP) Modulating Rheumatoid Arthritis
Sponsor:
Alloksys Life Sciences B.V.
Organization:
Study Overview
Official Title:
An OPEN LABEL Phase II Safety Study of Bovine Intestinal Alkaline Phosphatase (bIAP), an Inflammation Modulating Moiety, in RA Patients
Status:
COMPLETED
Status Verified Date:
2015-03
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:
ALS-003-2008
Brief Summary:
This is a proof of concept study asking if alkaline phosphatase injections can reduce acute inflammation in rheumatoid arthritis patients.
Detailed Description:
This is a proof of concept study to establish the safety of subcutaneous (sc) treatment and the efficacy of alkaline phosphatase (AP) in reducing specific pro-inflammatory cytokines during and after 3 days of twice daily s.c. treatment. A total dose of 12000 Units AP will be administered by 2000 IU s.c. injection twice daily for 3 days. Subjects will be closely followed for 8 days and regular clinical observations will be made during 3 months. Close out will be 3 months after initiation of treatment.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-007346-63 | EUDRACT_NUMBER | None | View |