Trial Condition(s):

Blood Coagulation Disorders, Hemophilia A

Effekt-2 - Efficacy and Safety of long-term treatment with KOGENATE® FS in Latin America

Bayer Identifier:

14285

ClinicalTrials.gov Identifier:

NCT00969319

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

Inclusion Criteria
:

 - Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® 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
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
105
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, Mexico

Status
Completed
 
Locations

Investigative Site

Many locations, Venezuela

Status
Completed
 

Trial Design