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Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00189982
First received: September 8, 2005
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101.


Condition Intervention Phase
Hemophilia A
Drug: Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins (ADVATE rAHF-PFM): Safety Monitoring in Pediatric Patients Diagnosed With Severe to Moderately Severe Hemophilia A - A Continuation of Baxter Clinical Study 060101

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences

Secondary Outcome Measures:
  • Assessment of the hemostatic efficacy in the treatment of bleeding episodes;
  • assessment of the hemostatic efficacy in surgical or invasive procedures

Enrollment: 4
Study Start Date: December 2004
Study Completion Date: November 2006
Intervention Details:
    Drug: Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)

    Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). Once the treatment regimen was established, the regimen was to be maintained for the duration of the study, unless clinical reasons necessitated a change.

    The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have participated and completed participation in Baxter's clinical study 060101
  • Subject or parent/legally authorized representative has provided written informed consent

Exclusion Criteria:

  • Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study
  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: NCT00189982

Locations
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Victor Blanchette, MD Hospital for Sick Children, Division of Hematology/Oncology, Toronto, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189982     History of Changes
Other Study ID Numbers: 060401
Study First Received: September 8, 2005
Last Updated: July 22, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Baxter Healthcare Corporation:
Factor VIII Deficiency

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Factor VIII
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014