Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

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.

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Key information

Conditions

Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Biological

Patients under daily life treatment receiving Kogenate according to local drug information.

Primary outcomes

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

Adverse event collection

Time frame: After 12 months and after 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2014
First posted: Sep 1, 2009
Registry last updated: Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed