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Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00969319
First received: August 31, 2009
Last updated: January 16, 2015
Last verified: January 2015
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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.
| Condition | Intervention |
|---|---|
| Blood Coagulation Disorders Hemophilia A | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Adverse event collection [ Time Frame: After 12 months and after 24 months ]
Biospecimen Retention: None Retained
n.a.
| Enrollment: | 105 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2014 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients under daily life treatment receiving Kogenate according to local drug information.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969319
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969319
Locations
| Mexico | |
| Many locations, Mexico | |
| Venezuela | |
| Many locations, Venezuela | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00969319 History of Changes |
| Other Study ID Numbers: |
14285 KG0802 ( Other Identifier: company internal ) |
| Study First Received: | August 31, 2009 |
| Last Updated: | January 16, 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 |
ClinicalTrials.gov processed this record on June 22, 2017