Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Kogenate (BAY 14-2222) (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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 KogenateŽ-FS raised in a Baby Hamster
Kidney cell line.
Clinical Details
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 (KogenateŽ FS).
Study design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: The primary outcome is 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.
Eligibility
Minimum age: 10 Years.
Maximum age: 60 Years.
Gender(s): Male.
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
- Written informed consent by subject and parent/legal representative, if < 18 years
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
Locations and Contacts
Detroit, Michigan 48202, United States
Las Vegas, Nevada 89109, United States
Additional Information
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Starting date: May 2006
Ending date: October 2006
Last updated: June 2, 2008
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