Trial Condition(s):
Blood Coagulation Disorders
Effekt-2 - Efficacy and Safety of long-term treatment with KOGENATE® FS in Latin America
Bayer Identifier:
14285
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Exclusion Criteria
No Exclusion Criteria Available
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, Mexico | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many locations, Venezuela | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Effekt-2 - Efficacy and Safety of long-term treatment with KOGENATE® FS in Latin America
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
- Total consumption of FVIIITimeframe: After 12 months and after 24 months
- Number of bleedingsTimeframe: After 12 months and after 24 months
- Kind of bleedingsTimeframe: After 12 months and after 24 months
- Continuation of therapyTimeframe: After 12 months and after 24 months
- Overall assessment by the physicianTimeframe: After 12 months and after 24 months
Secondary Outcome
- Adverse event collectionTimeframe: After 12 months and after 24 months
Additional Information
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