Trial Condition(s):

Hemophilia A

Non-interventional Observation of Practical implementation, Efficacy and safety of Continuous infusion with KOGENATE Bayer in Surgery (NO PEACKS)

Bayer Identifier:

13213

ClinicalTrials.gov Identifier:

NCT00922597

EudraCT Number:

Not Available

Study Completed

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.

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.
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
26
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many Locations, Slovenia

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Austria

Status
Completed
 
Locations

Investigative Site

Many Locations, Greece

Status
Completed
 

Trial Design