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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01386268
Other study ID # 14927
Secondary ID KG0910KR
Status Completed
Phase N/A
First received June 14, 2011
Last updated August 20, 2014
Start date June 2011
Est. completion date August 2013

Study information

Verified date August 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date August 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety variables will be summarized using descriptive statistics based on adverse events collection Up to 6 months Yes
Secondary Type of the treatment (prophylaxis, on demand, surgery) Initial visit and 6 month f/u or at the end of the observation visit No
Secondary Total consumption of FVIII Initial visit and 6 month f/u or at the end of the observation visit No
Secondary Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively) Initial visit, 6 month follow-up visit and 12 month follow-up visit No
Secondary General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient 6 month f/u or at the end of observation visit No
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