Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874926
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date April 2, 2009
First Posted Date April 3, 2009
Last Update Posted Date January 29, 2014
Study Start Date June 2008
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2009)
Efficacy and Safety of Kogenate Bayer/FS [ Time Frame: After 12 months, after 24 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00874926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Official Title Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Haemophilia A patients, no specific study population
Condition Hemophilia A
Intervention Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Haemophilia A patients
Study Groups/Cohorts Group 1
Intervention: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 6, 2013)
405
Original Estimated Enrollment
 (submitted: April 2, 2009)
150
Actual Study Completion Date April 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan,   Bahrain,   Bosnia and Herzegovina,   Croatia,   Germany,   Israel,   Kuwait,   Libyan Arab Jamahiriya,   Morocco,   Oman,   Qatar,   Romania,   Russian Federation,   Saudi Arabia,   Slovenia,   Tunisia,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT00874926
Other Study ID Numbers 13405
KG0702 ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date January 2014