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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

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Factor VIII Deficiency

Eligibility Criteria

undefined - 6 Years (Child)MaleDoes not accept 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or parent/legally authorized representative has provided written informed consent Exclusion Criteria: Subjects who have withdrawn from Baxter's Clinical Study 060101 prior to the termination of the study

Sites / Locations

Hospital for Sick Children

Outcomes

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

Full Information

NCT ID

NCT00189982

First Posted

September 8, 2005

Last Updated

May 3, 2021

Sponsor

Baxalta now part of Shire

1. Study Identification

Unique Protocol Identification Number

NCT00189982

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

December 17, 2004 (Actual)

Primary Completion Date

November 10, 2006 (Actual)

Study Completion Date

November 10, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxalta now part of Shire

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Factor VIII Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assessment of safety, as measured by the incidence, causality, and severity of adverse experiences

Time Frame

Throughout the study period of approximately 23 months.

Secondary Outcome Measure Information:

Title

Assessment of the hemostatic efficacy in the treatment of bleeding episodes;

Time Frame

At least 50 exposure days or a total treatment time of 6 months, whichever came first.

Title

assessment of the hemostatic efficacy in surgical or invasive procedures

Time Frame

From day of surgery until time of discharge from hospital or clinic (up to approximately 2 weeks post surgery).

10. Eligibility

Sex

Male

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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