EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00874926
First received: April 2, 2009
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.


Condition Intervention
Hemophilia A
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 405
Study Start Date: June 2008
Study Completion Date: April 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Haemophilia A patients, no specific study population

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874926

  Hide Study Locations
Locations
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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00874926     History of Changes
Other Study ID Numbers: 13405, KG0702
Study First Received: April 2, 2009
Last Updated: January 28, 2014
Health Authority: Bosnia: Federal Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Kazakhstan: Ethical Commission
Morocco: Ministry of Public Health
Croatia: Ethics Committee
Israel: Ethics Commission
Russia: Ethics Committee
Slovenia: Ethics Committee
Romania: Ethics Committee
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
Tunisia: Office of Pharmacies and Medicines
Lybia: Ethics Committee

Keywords provided by Bayer:
Octocog alfa
Haemophilia A

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

ClinicalTrials.gov processed this record on August 28, 2014