NCT00221195

Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors

A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Tulane University School of Medicine · Academic / Other
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemophilia A With Inhibitors

Interventions

Type	Name	Description
DRUG	activated prothrombin complex concentrate (FEIBA)	FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Timeline

• Start date: 2003-06-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2005-09-22
• Last updated: 2020-03-02
• Results posted: 2017-02-06

Locations

1 site across 1 country: United States