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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. The completion date has passed and the status has not been verified in more than two years.
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:


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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University School of Medicine
Investigators
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, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Thrombin
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on December 05, 2016