EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Bahrain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Biological

Haemophilia A patients

Primary outcomes

Efficacy and Safety of Kogenate Bayer/FS

Time frame: After 12 months, after 24 months

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2013
First posted: Apr 3, 2009
Registry last updated: Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed