EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222) (Biological)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Efficacy and Safety of Kogenate Bayer/FS
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their
only source of FVIII, decision taken by the investigator to administer KOGENATE
Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor
assessment within three months prior to enrollment should be available; for
pretreated patients with less than 100 exposure days an inhibitor assessment at
baseline should be available.
Exclusion Criteria:
- Exclusion criteria must be read in conjunction with the local product information.
Locations and Contacts
Many Locations, Bahrain
Many Locations, Bosnia and Herzegovina
Many Locations, Croatia
Many Locations, Germany
Many Locations, Israel
Many Locations, Kazakhstan
Many Locations, Kuwait
Many Locations, Libyan Arab Jamahiriya
Many Locations, Morocco
Many Locations, Oman
Many Locations, Qatar
Many Locations, Romania
Many Locations, Russian Federation
Many Locations, Saudi Arabia
Many Locations, Slovenia
Many Locations, Tunisia
Many Locations, United Arab Emirates
Additional Information
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Starting date: June 2008
Last updated: January 28, 2014
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