Trial Condition(s):

Hemophilia A

EFFEKT - Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS

Bayer Identifier:

13405

ClinicalTrials.gov Identifier:

NCT00874926

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

Inclusion Criteria
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the local product information.

Trial Summary

Enrollment Goal
405
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, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, Israel

Status
Completed
 
Locations

Investigative Site

Many Locations, Romania

Status
Completed
 
Locations

Investigative Site

Many Locations, Morocco

Status
Completed
 
Locations

Investigative Site

Many Locations, Oman

Status
Completed
 
Locations

Investigative Site

Many Locations, Bahrain

Status
Terminated
 
Locations

Investigative Site

Many Locations, United Arab Emirates

Status
Completed
 
Locations

Investigative Site

Many Locations, Tunisia

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, Slovenia

Status
Completed
 
Locations

Investigative Site

Many Locations, Croatia

Status
Completed
 
Locations

Investigative Site

Many Locations, Saudi Arabia

Status
Terminated
 
Locations

Investigative Site

Many Locations, Kuwait

Status
Terminated
 
Locations

Investigative Site

Many Locations, Kazakhstan

Status
Completed
 
Locations

Investigative Site

Many Locations, Qatar

Status
Terminated
 
Locations

Investigative Site

Many Locations, Libya

Status
Completed
 
Locations

Investigative Site

Many Locations, Bosnia and Herzegovina

Status
Completed
 

Trial Design