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

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189982
• Other study ID #: 060401
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 17, 2004
• Est. completion date: November 10, 2006

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 10, 2006
• Est. primary completion date: November 10, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 6 Years

Eligibility

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• Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Related Conditions & MeSH terms

• Hemophilia A

Intervention

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.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences		Throughout the study period of approximately 23 months.
Secondary	Assessment of the hemostatic efficacy in the treatment of bleeding episodes;		At least 50 exposure days or a total treatment time of 6 months, whichever came first.
Secondary	assessment of the hemostatic efficacy in surgical or invasive procedures		From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery).