Kogenate FS Regulatory Post-Marketing Surveillance (KG0910KR)

August 20, 2014 updated by: Bayer

KOGENATE® FS , Local Post Authorization Safety Study

To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hemophilia A in Korea

Description

Inclusion Criteria:

  • Patients with diagnosis of hemophilia A
  • Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
  • Signed the informed consent form to participate in this study.
  • 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
  • For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
  • Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

  • Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Type of the treatment (prophylaxis, on demand, surgery)
Time Frame: Initial visit and 6 month f/u or at the end of the observation visit
Initial visit and 6 month f/u or at the end of the observation visit
Total consumption of FVIII
Time Frame: Initial visit and 6 month f/u or at the end of the observation visit
Initial visit and 6 month f/u or at the end of the observation visit
Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)
Time Frame: Initial visit, 6 month follow-up visit and 12 month follow-up visit
Initial visit, 6 month follow-up visit and 12 month follow-up visit
General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient
Time Frame: 6 month f/u or at the end of observation visit
6 month f/u or at the end of observation visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14927
  • KG0910KR (Other Identifier: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Recombinant Factor VIII (Kogenate FS, BAY14-2222)

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Conditions

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Locations

3
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