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 | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Romania | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Morocco | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Oman | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bahrain | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Arab Emirates | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Tunisia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovenia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Croatia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kuwait | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Qatar | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Libya | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bosnia and Herzegovina | Status Completed | 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
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