Trial Condition(s):

Hemophilia A

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

Bayer Identifier:

12112

ClinicalTrials.gov Identifier:

NCT00621673

EudraCT Number:

Not Available

Terminated/Withdrawn

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
1
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Hemophilia Treatment Center of Las Vegas

Las Vegas, United States, 89109

Status
Completed
 
Locations

Henry Ford Health System

Detroit, United States, 48202

Status
Terminated
 

Trial Design