check_circleStudy Completed
Hemophilia A
Bayer Identifier:
11876
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Pharmacokinetics and safety of a single intravenous infusion of BAY 79-4980
Trial purpose
The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.
Key Participants Requirements
Sex
MaleAge
12 - 60 YearsTrial summary
Enrollment Goal
27Trial Dates
September 2005 - March 2006Phase
Phase 1Could I Receive a placebo
NoProducts
Kogenate FS Liposome (Recomb. F VIII, BAY79-4980)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | University of California - Davis | Davis, 95616, United States |
Completed | Children's Hospital of Orange County | Orange, 92868-3974, United States |
Primary Outcome
- To determine the pk profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPsdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
Secondary Outcome
- To determine the infusion tolerability of both BAY 79-4980 doses, by evaluation of vital signs and adverse eventsdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
- To determine the safety of both BAY 79-4980 doses by measuring the effects on laboratory parameters - especially the lipid profile and adverse eventsdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
- To determine the pk characteristics of liposomes - esp body clearance by measuring the major liposome component 1-palmitoyl-2-oleoyl-sn-glycerol-3-phosphocholine (POPC) and the non-biological liposome component, MPEG 2000 DSPE, as surrogate markerdate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
- To determine the activity of rFVIII over time (as determined by thrombin generation assay and the rotation thromboelastography [RoTEG] assay) for both doses of BAY 79-4980 compared to rFVIII-FSdate_rangeTime Frame:6 weeksenhanced_encryptionnoSafety Issue:
- Additional analyses of the number and timing of spontaneous bleeds after each study treatment will be assesseddate_rangeTime Frame:6 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
4