Brief Title
ADVATE Post Authorization Safety Surveillance
Official Title
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
Brief Summary
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
Study Type
Observational
Condition
Hemophilia A
Intervention
rAHF-PFM
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
Drug
Estimated Enrollment
108
Start Date
October 14, 2004
Completion Date
March 2, 2007
Eligibility Criteria
Inclusion Criteria: - Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%) - Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method) - Subject has been prescribed ADVATE by their treating physician - Subject may be of any age - Subject or parent/legally authorized representative has provided written informed consent Exclusion Criteria: - None
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00214734
Organization ID
ADVATE PASS
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Collaborators
Baxter BioScience
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
March 2021