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NCT00221195 Clinical Trial

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

Hemophilia A With Inhibitors Clinical Trial

— ProFEIBA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00221195
Other study ID # PRO-FEIBA Study
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2003
Est. completion date July 2010

Study information
Verified date February 2020
Source Tulane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date July 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 24 Months and older
Eligibility Inclusion Criteria:

- hemophilia A, any severity, with documented history 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Tulane University School of Medicine New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Tulane University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Bleeds During 6 Month Treatment Period 6 months
See also
  Status Clinical Trial Phase
Completed NCT00231751 - The Malmö International Brother Study (MIBS) N/A
Terminated NCT02484638 - Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors Phase 2/Phase 3
Terminated NCT00212472 - International Immune Tolerance Study N/A
Withdrawn NCT03002480 - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography N/A
Completed NCT03093480 - A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study) Phase 4
Completed NCT02448680 - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa Phase 3
Active, not recruiting NCT01105546 - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors Phase 2
Completed NCT02020369 - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX Phase 3