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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Tulane University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tulane University School of Medicine
ClinicalTrials.gov Identifier:
NCT00221195
First received: September 19, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 19, 2005
September 19, 2005
June 2003
Not Provided
Reduction in the number of bleeds
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Prospective, Randomized, Cross-Over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors
Not Provided

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Hemophilia A With Inhibitors
Drug: activated prothrombin complex concentrate (FEIBA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
Not Provided
Not Provided

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
Both
24 Months and older
No
Contact: Cindy A Leissinger, MD 504-390-2152 cleissi@cox-internet.com
United States
 
NCT00221195
PRO-FEIBA Study
Not Provided
Not Provided
Tulane University School of Medicine
Not Provided
Principal Investigator: Cindy A Leissinger Tulane University School of Medicine
Tulane University School of Medicine
September 2005

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