Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
- Registration Number
- NCT00621673
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 1
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Kogenate (BAY 14-2222) -
- Primary Outcome Measures
Name Time Method 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. 6 months
- Secondary Outcome Measures
Name Time Method 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. 6 months