Kogenate FS Regulatory Post-Marketing Surveillance

Bayer64 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hemophilia A

Interventions

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Many Locations, South Korea

Outcomes

Primary Outcomes

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

Time frame: Up to 6 months

Secondary Outcomes

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

Total consumption of FVIII

Time frame: 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

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

Data from ClinicalTrials.gov

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