check_circleStudy Completed
Hemophilia A, Hemophilia B
Bayer Identifier:
13787
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study of FVIIa variant BAY86-6150 (B0189) in subjects with moderate or severe hemophilia types A or B with or without inhibitors
Trial purpose
This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.
Key Participants Requirements
Sex
MaleAge
18 - 65 YearsTrial summary
Enrollment Goal
16Trial Dates
January 2009 - December 2009Phase
Phase 1Could I Receive a placebo
YesProducts
BAY86-6150Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hammersmith Hospital | London, W12 0HS, United Kingdom |
Completed | Instytut Hematologii i Transfuzjologii | Warszawa, 02-776, Poland |
Completed | University of Witwatersrand | JOHANNESBURG, 2193, South Africa |
Completed | University of the Free State | Bloemfontein, 9300, South Africa |
Primary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to Day 50enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Pharmacokinetic assessment, based on plasma concentration of BAY86-6150date_rangeTime Frame:9 time points from pre-dosing on Day 1 up to 48 hours post-dosingenhanced_encryptionNoSafety Issue:
- Pharmacodynamic assessment, based on plasma hemostasis marker leveldate_rangeTime Frame:9 time points from pre-dosing on Day 1 up to 48 hours post-dosingenhanced_encryptionNoSafety Issue:
- Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levelsdate_rangeTime Frame:3 time points from pre-dosing on Day 1 up to Day 50enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Factorial AssignmentTrial Arms
4