Efficacy, Safety and Pharmacokinetics Study of a rFVIII in Chinese subjects with Hemophilia A.To assess efficacy and safety of rFVIII administered as treatment and as on-demand therapy in adult and adolescent (12-65 years) patients with severe or moderately severe Hemophilia A. To determine the pharmacokinetic (PK) parameters of rFVIII.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Anhui provincial hospital
Hefei, Anhui, China
RECRUITINGRuijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGSecond hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Recovery rate = (change actual value of rFVIII activity before and after infusion )/(change expected value of rFVIII activity before and after infusion)*100%
Time frame: At 15 and 60 minutes after the first infusion
Investigator Hemostatic Efficacy Assessment 6 Hours Post Infusion
The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).
Time frame: 6 hours post infusion
The proportion of subjects who achieved the expected effect after the first infusion of the rFVIII
Time frame: At 15 minutes after the first infusion
change actual value of rFVIII activity before and after infusion levels
Time frame: At 15 and 60 minutes after the first infusion
FVIII Maximum Plasma Concentration
Time frame: Time Frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 6, 9, 24,36,and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration
Time frame: Time Frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 6, 9, 24,36,and 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours
Time frame: Time Frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 6, 9, 24,36,and 48 hours post-dose
Terminal Elimination Half-Life (t1/2)
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Blood Diseases Hospital, Chinese Academy of Medical Science (Institute of Hematology)
Tianjin, Tianjin Municipality, China
RECRUITINGTime frame: Time Frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 6, 9, 24,36,and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Time Frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 6, 9, 24,36,and 48 hours post-dose