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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
  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
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

Resource links provided by NLM:


Further study details as provided by Cindy Leissinger MD, Tulane University School of Medicine:

Primary Outcome Measures:
  • Reduction in the Number of Bleeds [ Time Frame: 6 months ]

Enrollment: 34
Study Start Date: June 2003
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
On-demand first
Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
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

Prophylaxis first
Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
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


  Eligibility

Ages Eligible for Study:   24 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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):
Responsible Party: Cindy Leissinger MD, Professor, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT00221195     History of Changes
Other Study ID Numbers: PRO-FEIBA Study
Study First Received: September 19, 2005
Results First Received: December 12, 2016
Last Updated: December 12, 2016

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Thrombin
Coagulants
Hemostatics

ClinicalTrials.gov processed this record on July 19, 2017