Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery (NO PEACKS)

Bayer

Status: Completed

Conditions: Hemophilia A

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00922597

13213

KG0701 (Other Identifier)

Details and patient eligibility

About

The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.

Enrollment: 26 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• In-patients with diagnosis of severe haemophilia A (FVIII < 1%), heavily pretreated (> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.

Trial design

26 participants in 1 patient group

Group 1

Treatment:

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