check_circleStudy Completed
Hemophilia A
Bayer Identifier:
11145
ClinicalTrials.gov Identifier:
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
MaleAge
0 N/ATrial summary
Enrollment Goal
200Trial Dates
December 2002 - December 2005Phase
N/ACould I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A