EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

Bayer

Status: Completed

Conditions: Hemophilia A

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00932555

14344

KG0803 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

82 participants in 1 patient group

Group 1

Treatment:

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