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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
  Purpose

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:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

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
  Eligibility

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

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

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

Locations
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
Investigators
Principal Investigator: Cindy A Leissinger Tulane University School of Medicine
  More Information

No publications provided by Tulane University School of Medicine

Additional 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, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
 Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013