Brief Title
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Official Title
AN OPEN-LABEL STUDY OF THE SAFETY AND EFFICACY OF REFACTO AF IN PREVIOUSLY UNTREATED PATIENTS IN USUAL CARE SETTINGS
Brief Summary
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.
Detailed Description
Regulatory Commitment
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants Who Developed Clinically Significant Factor VIII (FVIII) Inhibitors During the Course of the Study
Secondary Outcome
Annualized Bleeding Rate (ABR)
Condition
Hemophilia A
Intervention
Laboratory Tests
Study Arms / Comparison Groups
1
Description: The investigator treats subjects with ReFacto AF in the usual care setting.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
23
Start Date
February 10, 2010
Completion Date
November 24, 2016
Primary Completion Date
November 24, 2016
Eligibility Criteria
Inclusion Criteria: - Male subjects <6 years of age with severe hemophilia A (FVIII:C <1%) based on clinical records, including newborns. - No prior exposure to factor products or any blood products. Exclusion Criteria: - Presence of any bleeding disorder in addition to hemophilia A. - Treatment with any investigational agent or device within the past 30 days. - Any condition(s) that compromises the ability to collect study-related observations, or that poses a contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; and expectation of poor adherence to study requirements).
Gender
Male
Ages
N/A - 6 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00950170
Organization ID
3082B2-4434
Secondary IDs
B1831006
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
May 2019