International PMS Study - KOGENATE Bayer

Bayer

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: Kogenate (BAY14-2222)

Study type: Observational

Funder types: Industry

Identifiers

NCT00864552

12261 - KG0201FR,

12264 - KG0201SE,

12259 - KG0201GR,

12252 - KG0201CH,

12253 - KG0201BE,

12260 - KG0201ES,

12256 - KG0201AT,

12266 - KG0201NL

11145

12258 - KG0201IT,

Details and patient eligibility

About

To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.

To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Enrollment: 200 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII

Exclusion criteria

• Exclusion criteria must be read in conjunction with the product information (SmPC)

Trial design

200 participants in 1 patient group

Group 1

Treatment:

Drug: Kogenate (BAY14-2222)