The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg. The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
UCSF School of Medicine
San Francisco, California, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
Dr. William Mitchell New York Blood Center, Weill Cornell Medical College
New York, New York, United States
FX:C Incremental Recovery
Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg). Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Time frame: At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)
FX:C Half-life
Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Time frame: At Baseline and at 6 months post-Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dr Gunter Auerswald
Bremen, Germany
Dr. Bermejo
Cáceres, Spain
Dr Maite Alvarez
Madrid, Spain
Cukurova University Hospital
Balcali, Adana, Turkey (Türkiye)
Ministry of Health Istanbul Goztepe Training & Research Hospital
Göztepe, Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa School of Medicine
Istanbul, Turkey (Türkiye)
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
...and 4 more locations