check_circleStudy Completed

Hemophilia A

Bayer Identifier:

13405

ClinicalTrials.gov Identifier:

NCT00874926

EudraCT Number:

Not Available

EU CT Number:

Not Available
EFFEKT - Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS

Trial 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.

Key Participants Requirements

Sex

Male

Age

0 - N/A
  • - 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 must be read in conjunction with the local product information.

Trial summary

Enrollment Goal
405
Trial Dates
June 2008 - April 2013
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, Israel
Completed
Many Locations, Romania
Completed
Many Locations, Morocco
Completed
Many Locations, Oman
Terminated
Many Locations, Bahrain
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, Tunisia
Completed
Many Locations, Russia
Completed
Many Locations, Slovenia
Completed
Many Locations, Croatia
Terminated
Many Locations, Saudi Arabia
Terminated
Many Locations, Kuwait
Completed
Many Locations, Kazakhstan
Terminated
Many Locations, Qatar
Completed
Many Locations, Libya
Completed
Many Locations, Bosnia and Herzegovina

Primary Outcome

  • Efficacy and Safety of Kogenate Bayer/FS
    date_rangeTime Frame:
    After 12 months, after 24 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Efficacy and Safety of long-term treatment with KOGENATE Bayer/FS
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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