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Trial record 13 of 2357 for:    "Blood Coagulation Disorders"
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Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00969319
First received: August 31, 2009
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  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:

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 ] [ Designated as safety issue: No ]
  • Number of bleedings [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
  • Kind of bleedings [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
  • Continuation of therapy [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]
  • Overall assessment by the physician [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: After 12 months and after 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 103
Study Start Date: June 2009
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2012 (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

Genders 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
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:
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

No publications provided

Responsible Party: Regional Medical Director, Bayer de Mexico
ClinicalTrials.gov Identifier: NCT00969319     History of Changes
Other Study ID Numbers: 14285, KG0802
Study First Received: August 31, 2009
Last Updated: April 5, 2013
Health Authority: Mexico: Ethics Committee
Venezuela: Ethics Committee

Keywords provided by Bayer:
Octocog alfa
Hemophilia A

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hemophilia A
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
 Coagulation Protein Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013