check_circleStudy Completed

Hemophilia A

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

Male

Age

12 - 60 Years

Trial summary

Enrollment Goal
27
Trial Dates
September 2005 - March 2006
Phase
Phase 1
Could I Receive a placebo
No
Products
Kogenate FS Liposome (Recomb. F VIII, BAY79-4980)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of California - DavisDavis, 95616, United States
Completed
Children's Hospital of Orange CountyOrange, 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 PTPs
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To determine the infusion tolerability of both BAY 79-4980 doses, by evaluation of vital signs and adverse events
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • To determine the safety of both BAY 79-4980 doses by measuring the effects on laboratory parameters - especially the lipid profile and adverse events
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • 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 marker
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • 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-FS
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Additional analyses of the number and timing of spontaneous bleeds after each study treatment will be assessed
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A randomized, double-blind, cross-over study to determine the pharmacokinetics and safety of a single intravenous infusion of BAY 79-4980 in previously treated patients with severe hemophilia A
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
4