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OpenTrials
Completed

NCT Number: NCT01386268

Kogenate FS Regulatory Post-Marketing Surveillance

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Biological

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

Primary outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: Up to 6 months

Secondary outcomes

  1. 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

  2. Total consumption of FVIII

    Time frame: Initial visit and 6 month f/u or at the end of the observation visit

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

KOGENATE® FS , Local Post Authorization Safety Study

Acronym: KG0910KR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2011
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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