Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Bayer

Status: Completed

Conditions: Hemophilia A; Blood Coagulation Disorders

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00969319

14285

KG0802 (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: 105 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

105 participants in 1 patient group

Group 1

Treatment:

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