Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
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ClinicalTrials.gov Identifier: NCT00969319 |
Recruitment Status
:
Completed
First Posted
: September 1, 2009
Last Update Posted
: January 19, 2015
|
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Condition or disease | Intervention/treatment |
---|---|
Blood Coagulation Disorders Hemophilia A | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
Study Type : | Observational |
Actual Enrollment : | 105 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2014 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1 |
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients under daily life treatment receiving Kogenate according to local drug information.
|
- Total consumption of FVIII [ Time Frame: After 12 months and after 24 months ]
- Number of bleedings [ Time Frame: After 12 months and after 24 months ]
- Kind of bleedings [ Time Frame: After 12 months and after 24 months ]
- Continuation of therapy [ Time Frame: After 12 months and after 24 months ]
- Overall assessment by the physician [ Time Frame: After 12 months and after 24 months ]
- Adverse event collection [ Time Frame: After 12 months and after 24 months ]
Biospecimen Retention: None Retained

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969319
Mexico | |
Many locations, Mexico | |
Venezuela | |
Many locations, Venezuela |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00969319 History of Changes |
Other Study ID Numbers: |
14285 KG0802 ( Other Identifier: company internal ) |
First Posted: | September 1, 2009 Key Record Dates |
Last Update Posted: | January 19, 2015 |
Last Verified: | January 2015 |
Keywords provided by Bayer:
Octocog alfa Hemophilia A |
Additional relevant MeSH terms:
Hemophilia A Blood Coagulation Disorders Hemostatic Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Factor VIII Coagulants |