ADVATE Post Authorization Safety Surveillance
Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
October 14, 2004
March 2, 2007
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
N/A - N/A
Accepts Healthy Volunteers
Study Director, ,
Baxalta now part of Shire
Study Director, Study Director, Takeda