Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT01538160
Status:
UNKNOWN
Last Update Posted:
2012-02-23
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
NOT_YET_RECRUITING
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:
rFVIIa
Brief Summary:
Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.
Detailed Description:
Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.
Study Oversight
Has Oversight DMC:
False
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?: