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

Bayer

Status and phase

Terminated

Phase 4

Conditions

Hemophilia A

Treatments

Drug: Kogenate (BAY 14-2222)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00621673

12112

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

Male

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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