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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

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.

Starting date: June 2008
Last updated: January 28, 2014

Page last updated: August 23, 2015

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