check_circleStudy Completed
Hemophilia A
Bayer Identifier:
13405
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
EFFEKT - Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS
Trial purpose
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.
Key Participants Requirements
Sex
MaleAge
0 - N/ATrial summary
Enrollment Goal
405Trial Dates
June 2008 - April 2013Phase
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, Germany | |
Completed | Many Locations, Israel | |
Completed | Many Locations, Romania | |
Completed | Many Locations, Morocco | |
Completed | Many Locations, Oman | |
Terminated | Many Locations, Bahrain | |
Completed | Many Locations, United Arab Emirates | |
Completed | Many Locations, Tunisia | |
Completed | Many Locations, Russia | |
Completed | Many Locations, Slovenia | |
Completed | Many Locations, Croatia | |
Terminated | Many Locations, Saudi Arabia | |
Terminated | Many Locations, Kuwait | |
Completed | Many Locations, Kazakhstan | |
Terminated | Many Locations, Qatar | |
Completed | Many Locations, Libya | |
Completed | Many Locations, Bosnia and Herzegovina |
Primary Outcome
- Efficacy and Safety of Kogenate Bayer/FSdate_rangeTime Frame:After 12 months, after 24 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
Biological/VaccineTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A