EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00874926 |
Recruitment Status :
Completed
First Posted : April 3, 2009
Last Update Posted : January 29, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Hemophilia A | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
Study Type : | Observational |
Actual Enrollment : | 405 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | April 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Group 1 |
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients |
- Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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): NCT00874926
Bahrain | |
Many Locations, Bahrain | |
Bosnia and Herzegovina | |
Many Locations, Bosnia and Herzegovina | |
Croatia | |
Many Locations, Croatia | |
Germany | |
Many Locations, Germany | |
Israel | |
Many Locations, Israel | |
Kazakhstan | |
Many Locations, Kazakhstan | |
Kuwait | |
Many Locations, Kuwait | |
Libyan Arab Jamahiriya | |
Many Locations, Libyan Arab Jamahiriya | |
Morocco | |
Many Locations, Morocco | |
Oman | |
Many Locations, Oman | |
Qatar | |
Many Locations, Qatar | |
Romania | |
Many Locations, Romania | |
Russian Federation | |
Many Locations, Russian Federation | |
Saudi Arabia | |
Many Locations, Saudi Arabia | |
Slovenia | |
Many Locations, Slovenia | |
Tunisia | |
Many Locations, Tunisia | |
United Arab Emirates | |
Many Locations, United Arab Emirates |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00874926 |
Other Study ID Numbers: |
13405 KG0702 ( Other Identifier: company internal ) |
First Posted: | April 3, 2009 Key Record Dates |
Last Update Posted: | January 29, 2014 |
Last Verified: | January 2014 |
Octocog alfa Haemophilia A |
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Factor VIII Coagulants |