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: November 22, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

November 22, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00189982 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of the hemostatic efficacy in the treatment of bleeding episodes;
assessment of the hemostatic efficacy in surgical or invasive procedures

Original Secondary Outcome Measures ^ICMJE

- Assessment of the hemostatic efficacy in the treatment of bleeding episodes
- Assessment of the hemostatic efficacy in surgical or invasive procedures

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

Drug: Antihemophilic factor, recombinant, manufactured protein-free

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

up to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00189982

Other Study ID Numbers ^ICMJE

060401

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Victor Blanchette, MD

Hospital for Sick Children, Division of Hematology/Oncology, Toronto, Canada

Information Provided By

Baxter Healthcare Corporation

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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