Brief Title
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Official Title
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Brief 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.
Study Type
Observational
Primary Outcome
Total consumption of FVIII
Secondary Outcome
Adverse event collection
Condition
Blood Coagulation Disorders
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
105
Start Date
September 2009
Completion Date
February 2014
Primary Completion Date
February 2013
Eligibility Criteria
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.
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00969319
Organization ID
14285
Secondary IDs
KG0802
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
January 2015