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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cindy Leissinger MD, Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT00221195
First received: September 19, 2005
Last updated: December 12, 2016
Last verified: December 2016

September 19, 2005
December 12, 2016
June 2003
December 2009   (Final data collection date for primary outcome measure)
Reduction in the Number of Bleeds [ Time Frame: 6 months ]
Reduction in the Number of Bleeds
Complete list of historical versions of study NCT00221195 on ClinicalTrials.gov Archive Site
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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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Hemophilia A With Inhibitors
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

  • On-demand first
    Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
    Intervention: Drug: activated prothrombin complex concentrate (FEIBA)
  • Prophylaxis first
    Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
    Intervention: Drug: activated prothrombin complex concentrate (FEIBA)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
24 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00221195
PRO-FEIBA Study
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Cindy Leissinger MD, Tulane University School of Medicine
Tulane University School of Medicine
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Principal Investigator: Cindy A Leissinger Tulane University School of Medicine
Tulane University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP