EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00932555

First received: July 2, 2009

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2009

Last Updated Date

March 13, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00932555 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 Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

Official Title ^ICMJE

EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

Brief Summary

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.

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

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.

Condition ^ICMJE

Hemophilia A

Intervention ^ICMJE

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

Patients under daily life treatment receiving Kogenate according to local drug information.

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

Completion Date

December 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00932555

Other Study ID Numbers ^ICMJE

14344, KG0803

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Taiwan LTD

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

March 2012

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

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