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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00874926

First received: April 2, 2009

Last updated: February 6, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2009

Last Updated Date

February 6, 2013

Start Date ^ICMJE

June 2008

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00874926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Hemophilia A

Intervention ^ICMJE

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Haemophilia A patients

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

405

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bahrain, Bosnia and Herzegovina, Croatia, Germany, Israel, Kazakhstan, Kuwait, Libyan Arab Jamahiriya, Morocco, Oman, Qatar, Romania, Russian Federation, Saudi Arabia, Slovenia, Tunisia, United Arab Emirates

Administrative Information

NCT Number ^ICMJE

NCT00874926

Other Study ID Numbers ^ICMJE

13405, KG0702

Has Data Monitoring Committee

Responsible Party

Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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