Trial Condition(s):
Hemophilia A
International PMS Study - KOGENATE Bayer
Bayer Identifier:
11145
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
Inclusion Criteria
- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
Exclusion Criteria
- Exclusion criteria must be read in conjunction with the product information (SmPC)
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, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Switzerland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Denmark | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Sweden | Contact Us: E-mail: [email protected] Phone: Not Available |
For details, please refer to trial results
Additional Information
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