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NCT00874926 Clinical Trial

EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Hemophilia A Clinical Trial

Official title:
Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00874926
Other study ID # 13405
Secondary ID KG0702
Status Completed
Phase N/A
First received April 2, 2009
Last updated January 28, 2014
Start date June 2008
Est. completion date April 2013

Study information
Verified date January 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Bosnia: Federal Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesKazakhstan: Ethical CommissionMorocco: Ministry of Public HealthCroatia: Ethics CommitteeIsrael: Ethics CommissionRussia: Ethics CommitteeSlovenia: Ethics CommitteeRomania: Ethics CommitteeUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthTunisia: Office of Pharmacies and MedicinesLybia: Ethics Committee
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 405
Est. completion date April 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/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:

- Exclusion criteria must be read in conjunction with the local product information.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Bahrain,  Bosnia and Herzegovina,  Croatia,  Germany,  Israel,  Kazakhstan,  Kuwait,  Libyan Arab Jamahiriya,  Morocco,  Oman,  Qatar,  Romania,  Russian Federation,  Saudi Arabia,  Slovenia,  Tunisia,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy and Safety of Kogenate Bayer/FS After 12 months, after 24 months Yes
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