Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A

• Status: Terminated
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

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