Publication Date:
2009-11-20
Description:
Abstract 3141 Poster Board III-78 Introduction Studies assessing the safety, tolerability and efficacy of a licensed drug are of utmost value for caregivers, patients and authorities to overcome the shortcomings of pre-licensing trials and to obtain information on the behavior of a drug in routine clinical conditions. Moreover, there is a paucity of data addressing the clinical outcome of treatment strategies in patients with severe hemophilia A, an especially vulnerable subset that presents the highest prevalence of antibody inhibitors. Late onset inhibitors may arise in patients who have accumulated hundreds of exposure days or after an intensive treatment episode. Patients and methods To assess the immunogenicity and overall safety associated with long-term use of Alphanate®, a highly purified plasma-derived factor VIII concentrate containing high-molecular weight multimers of von Willebrand Factor, a prospective, non-randomized, multicenter, post-authorization surveillance study was initiated in 2002 with the intention of involving at least 50 evaluable patients. Only previously treated patients (PTPs) diagnosed with severe hemophilia A (
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine
Permalink