Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Assessment of the Risk of Inhibitor Formation in Subjects With Severe Hemophilia A When Switched From a Replacement Therapy With a rFVIII Produced by a Chinese Hamster Ovary (CHO) Cell Line to a rFVIII Produced by a Baby Hamster Kidney (BHK) Cell Line (Kogenate® FS).
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.
To evaluate whether a switch of replacement therapy from an rFVIII produced in a CHO cell line to an rFVIII produced in a BHK cell line is associated with a risk of inhibitor formation.
To quantify the risk of inhibitor formation, to assess the efficacy of the rFVIII-FS while on regular replacement therapy and to assess the quality-of-life (QoL) before and after the study.
Kogenate (BAY 14-2222)
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Inclusion Criteria: - Subjects with severe hemophilia A (< 2% FVIII:C) - Subjects with no history of FVIII inhibitor antibody formation - Subjects with no measurable inhibitor activity - Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months - Subjects whose current treatment with any CHO rFVIII product - Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study - Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency Exclusion Criteria: - Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease) - Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins - Any individual with a past history of severe reaction(s) to FVIII concentrates - Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry - Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry - Subjects who require any medication for FVIII infusions
12 Years - 60 Years
Accepts Healthy Volunteers
Bayer Study Director, ,
Bayer Study Director, Study Director, Bayer