Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284193
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2006-01-17
Brief Title:
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Patients with severe hemophilia and inhibitors can be treated effectively by Activated Prothrombin Complex Concentrates APCC eg FEIBA or High dose recombinant factor VIIa rFVIIa Rarely such patients develop refractoriness to these products for whom therapy with sequential FEIBA and rFVIIa has been recently suggested
The impetus for the present report was a hemophilia A patient with high titer inhibitor 1300BU who had life threatening hematuria that was resistant to repeated doses of 400µgkg rFVIIa up to a cumulative dose of 1200 µgkg given over 6-9 hours
Thrombin generation TG tested in vitro was consistent with resistance to high concentrations of rFVIIa but yielded good response to combinations of low doses of rFVIIaFEIBA In a desperate attempt to control the bleeding concomitant therapy of 25 Ukg FEIBA and 40µgkg rFVIIa was infused and resulted in arrest of bleeding within minutes Over a span of about one year the patient has been successfully treated by this combination for more than 200 bleeding episodes in muscles and joints
The impetus for the present report was a hemophilia A patient with high titer inhibitor 1300BU who had life threatening hematuria that was resistant to repeated doses of 400µgkg rFVIIa up to a cumulative dose of 1200 µgkg given over 6-9 hours
Thrombin generation TG tested in vitro was consistent with resistance to high concentrations of rFVIIa but yielded good response to combinations of low doses of rFVIIaFEIBA In a desperate attempt to control the bleeding concomitant therapy of 25 Ukg FEIBA and 40µgkg rFVIIa was infused and resulted in arrest of bleeding within minutes Over a span of about one year the patient has been successfully treated by this combination for more than 200 bleeding episodes in muscles and joints
Detailed Description:
Inhibitor patients with HR inhibitors were eligible for study enrollment After consent blood was drawn and ex- vivo spiked with rFVIIaFEIBA and combinations assayed by thrombin generation tests
The combination yielding sufficient hemostasis was depicted for patients therapy of future bleeding episodes
Following actual therapy hemostasis and safety parameters were monitored
The combination yielding sufficient hemostasis was depicted for patients therapy of future bleeding episodes
Following actual therapy hemostasis and safety parameters were monitored
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