Trial Condition(s):

Hemophilia A

International PMS Study - KOGENATE Bayer

Bayer Identifier:

11145

ClinicalTrials.gov Identifier:

NCT00864552

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Inclusion Criteria
- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the product information (SmPC)

Trial Summary

Enrollment Goal
200
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, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Greece

Status
Completed
 
Locations

Investigative Site

Many Locations, Austria

Status
Completed
 
Locations

Investigative Site

Many Locations, Belgium

Status
Completed
 
Locations

Investigative Site

Many Locations, Switzerland

Status
Completed
 
Locations

Investigative Site

Many Locations, Denmark

Status
Completed
 
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many Locations, Sweden

Status
Completed
 

For details, please refer to trial results

Additional Information