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
Information provided by:
Tulane University School of Medicine
ClinicalTrials.gov Identifier:
First received: September 19, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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.

Condition Intervention Phase
Hemophilia A With Inhibitors
Drug: activated prothrombin complex concentrate (FEIBA)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Tulane University School of Medicine:

Primary Outcome Measures:
  • Reduction in the number of bleeds

Estimated Enrollment: 42
Study Start Date: June 2003

Ages Eligible for Study:   24 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00221195

Contact: Cindy A Leissinger, MD 504-390-2152 cleissi@cox-internet.com

United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Cindy Leissinger, MD    504-390-2152    cleissi@cox-internet.com   
Sponsors and Collaborators
Tulane University School of Medicine
Principal Investigator: Cindy A Leissinger Tulane University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00221195     History of Changes
Other Study ID Numbers: PRO-FEIBA Study 
Study First Received: September 19, 2005
Last Updated: September 19, 2005
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 22, 2016