check_circleStudy Completed

Hemophilia A

Bayer Identifier:

13213

ClinicalTrials.gov Identifier:

NCT00922597

EudraCT Number:

Not Available

EU CT Number:

Not Available
Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery

Trial 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.

Key Participants Requirements

Sex

Male

Age

0 - N/A

  • - 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 summary

Enrollment Goal
26
Trial Dates
August 2008 - September 2011
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Netherlands
Completed
Many Locations, Slovenia
Completed
Many Locations, Germany
Completed
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Austria
Completed
Many Locations, Greece

Primary Outcome

  • 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
    date_rangeTime Frame:
    During continuous infusion
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • General tolerability and development of inhibitors
    date_rangeTime Frame:
    Within 14 days to 3 months after termination of continuous infusion
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery - NO PEACKS
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.