Overview

This trial is active, not recruiting.

Conditions blood coagulation disorders, hemophilia a
Treatment recombinant factor viii (kogenate fs, bay14-2222)
Sponsor Bayer
Start date September 2009
End date February 2013
Trial size 105 participants
Trial identifier NCT00969319, 14285, KG0802

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
recombinant factor viii (kogenate fs, bay14-2222)
Patients under daily life treatment receiving Kogenate according to local drug information.

Primary Outcomes

Measure
Total consumption of FVIII
time frame: After 12 months and after 24 months
Number of bleedings
time frame: After 12 months and after 24 months
Kind of bleedings
time frame: After 12 months and after 24 months
Continuation of therapy
time frame: After 12 months and after 24 months
Overall assessment by the physician
time frame: After 12 months and after 24 months

Secondary Outcomes

Measure
Adverse event collection
time frame: After 12 months and after 24 months

Eligibility Criteria

Male participants of any age.

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.

Additional Information

Official title Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Bayer.