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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00922597
First received: June 16, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hemophilia A
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery - NO PEACKS

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Total consumption of FVIII (in IU/kg) during continuous infusion, FVIII:C achieved compared to expected levels, reasons and number of unplanned bolus infusion, amount of blood loss, transfusion requirements [ Time Frame: During continuous infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General tolerability and development of inhibitors [ Time Frame: Within 14 days to 3 months after termination of continuous infusion ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: August 2009
Study Completion Date: September 2011
Groups/Cohorts Assigned Interventions
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of patients with a diagnosis of severe haemophilia A. Physicians should consult the full prescribing information for KOGENATE Bayer before enrolling patients and familiarize themselves with the safety information in the product information.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922597

Locations
Austria
Many Locations, Austria
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Italy
Many Locations, Italy
Netherlands
Many Locations, Netherlands
Slovenia
Many Locations, Slovenia
Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00922597     History of Changes
Other Study ID Numbers: 13213, KG0701
Study First Received: June 16, 2009
Last Updated: August 6, 2014
Health Authority: Austria: Department of Health
Spain: Regional Health Authorities
Greece: Ministry of Health and Welfare
Greece: National Organization of Medicines
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Slovenia: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Continuous infusion
Surgery
Severe haemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014