Trial Condition(s):
Hemophilia A
EFFEKT - Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS
Bayer Identifier:
13405
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Romania | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Morocco | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Oman | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bahrain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Tunisia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Croatia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Qatar | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Libya | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bosnia and Herzegovina | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS
Trial Type:
Observational
Intervention Type:
Biological/Vaccine
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Efficacy and Safety of Kogenate Bayer/FSTimeframe: After 12 months, after 24 months
Additional Information
Copyright © Bayer
Powered by
