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CompletedNCT01386268KG0910KRUpdated Aug 21, 2014

Kogenate FS Regulatory Post-Marketing Surveillance

An observational study in Hemophilia A, sponsored by Bayer. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2014-08-21.

Sponsored by Bayer · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
64
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hemophilia A

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Keywords

  • Kogenate FS
  • Hemophilia A
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 64 is below the median of 80 across 314 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with hemophilia A in Korea

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

Exclusion Criteria:

  • Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
05

Study design

Time perspective
Prospective
Enrollment
64 participants (actual)

Groups and cohorts

  • Group 1

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

Interventions

  • BiologicalRecombinant 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

06

What researchers measure

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

07

Study locations

1 site
  • Many locations, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01386268
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jul 1, 2011
Start date
Jun 2011
Primary completion
Jan 2013
Completion
Aug 2013
Last update
Aug 21, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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