check_circleStudy Completed
Hemophilia A
Bayer Identifier:
15495
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Comparative pharmacokinetic study of two different strengths of BAY14-2222
Trial purpose
This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
Key Participants Requirements
Sex
MaleAge
18 - 65 YearsTrial summary
Enrollment Goal
18Trial Dates
July 2012 - December 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD | Sofia, 1756, Bulgaria |
Primary Outcome
- Maximum plasma concentration (Cmax) of BAY14-2222date_rangeTime Frame:Up to 48 hoursenhanced_encryptionNoSafety Issue:
- Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222date_rangeTime Frame:Up to 48 hoursenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2