check_circleStudy Completed
Hemophilia A
Bayer Identifier:
14927
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Kogenate FS regulatory Post-Marketing Surveillance
Trial purpose
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.
The observation period for each patient is up to 6 months.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
64Trial Dates
June 2011 - August 2013Phase
N/ACould I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Korea, Republic Of |
Primary Outcome
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:Up to 6 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Type of the treatment (prophylaxis, on demand, surgery)date_rangeTime Frame:Initial visit and 6 month f/u or at the end of the observation visitenhanced_encryptionNoSafety Issue:
- Total consumption of FVIIIdate_rangeTime Frame:Initial visit and 6 month f/u or at the end of the observation visitenhanced_encryptionNoSafety Issue:
- Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)date_rangeTime Frame:Initial visit, 6 month follow-up visit and 12 month follow-up visitenhanced_encryptionNoSafety Issue:
- General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficientdate_rangeTime Frame:6 month f/u or at the end of observation visitenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
Biological/VaccineTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A