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

Bayer

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type: Observational

Funder types: Industry

Identifiers

NCT00874926

KG0702 (Other Identifier)

13405

Details and patient eligibility

About

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.

Enrollment: 405 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

405 participants in 1 patient group

Group 1

Treatment:

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)