EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Information source: Bayer
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Summary
The aim of this international prospective post-marketing surveillance study is to obtain
data on treatment procedures, long-term safety and efficacy and patient acceptance of
KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment
conditions.
Clinical Details
Official title: EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Efficacy and Safety of Kogenate FS
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE FS
as their only source of FVIII, decision taken by the investigator to administer
KOGENATE 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.
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Taiwan; Recruiting
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.
Starting date: April 2009
Last updated: September 19, 2011
|
