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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
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Blood Coagulation Disorders Hemophilia A Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Total consumption of FVIII [ Time Frame: After 12 months and after 24 months ]
  2. Number of bleedings [ Time Frame: After 12 months and after 24 months ]
  3. Kind of bleedings [ Time Frame: After 12 months and after 24 months ]
  4. Continuation of therapy [ Time Frame: After 12 months and after 24 months ]
  5. Overall assessment by the physician [ Time Frame: After 12 months and after 24 months ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: After 12 months and after 24 months ]

Biospecimen Retention:   None Retained
n.a.

Eligibility Criteria
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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
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Mexico
Many locations, Mexico
Venezuela
Many locations, Venezuela
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

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