A Prospective, Randomized, Cross-Over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2003 |
| Contact: | Cindy A Leissinger, MD |
| Email: | cleissi@cox-internet.com |
| Phone: | 504-390-2152 |
The objective of this study is to assess whether prophylactic therapy with an activated
prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number
of bleeds in patients with hemophilia and persistent high responding inhibitors.
prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number
of bleeds in patients with hemophilia and persistent high responding inhibitors.
Inclusion Criteria:
- hemophilia A, any severity, with documented hisotry of high-titer inhibitor (>5BU);
current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/=
6 bleeds requiring bypassing therapy in the previous 6 months
Exclusion Criteria:
- concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet
count less than 100,000
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