check_circleStudy Completed

Hemophilia A

Bayer Identifier:

11145

ClinicalTrials.gov Identifier:

NCT00864552

EudraCT Number:

Not Available

EU CT Number:

Not Available
International PMS Study - KOGENATE Bayer

Trial purpose

To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Key Participants Requirements

Sex

Male

Age

0 N/A
  • - Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
  • - Exclusion criteria must be read in conjunction with the product information (SmPC)

Trial summary

Enrollment Goal
200
Trial Dates
December 2002 - December 2005
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain
Completed
Many Locations, Greece
Completed
Many Locations, Austria
Completed
Many Locations, Belgium
Completed
Many Locations, Switzerland
Completed
Many Locations, Denmark
Completed
Many Locations, France
Completed
Many Locations, Italy
Completed
Many Locations, Netherlands
Completed
Many Locations, Sweden

Trial design

International PMS Study - KOGENATE Bayer
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.