Brief Title
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Official Title
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).
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
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.
Condition
Hemophilia A
Intervention
Kogenate (BAY 14-2222)
Study Arms / Comparison Groups
Arm 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
May 2006
Completion Date
October 2006
Eligibility 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
Gender
Male
Ages
12 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00621673
Organization ID
12112
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
December 2014