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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

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Starting date: April 2009
Last updated: September 19, 2011

Page last updated: December 08, 2011

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