Trial Condition(s):

Hemophilia A

Assessment of the risk of inhibitor formation in previously treated patients with severe hemophilia A

Bayer Identifier:

12112 Identifier:


EudraCT Number:

Not Available

EU CT Number:

Not Available


Trial Purpose

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.

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

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers

Where to Participate


Hemophilia Treatment Center of Las Vegas

Las Vegas, United States, 89109


Henry Ford Health System

Detroit, United States, 48202

Trial Design