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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189982

Enrollment

Registered

2005-09-19

Start date

2004-12-17

Completion date

2006-11-10

Last updated

2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Factor VIII Deficiency

Brief 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.

Interventions

DRUGAntihemophilic 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

No minimum to 6 Years

Healthy volunteers

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* Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Design outcomes

Primary

Measure	Time frame
Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences	Throughout the study period of approximately 23 months.

Secondary

Measure	Time frame
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.
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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026