This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital).
Pfizer Investigational Site
Suzhou, Jiangsu, China
Pfizer Investigational Site
Heping District, Tianjin Municipality, China
Pfizer Investigational Site
Hangzhou, Zhejiang, China
Pfizer Investigational Site
Beijing, China
Investigator Hemostatic Efficacy Assessment 8 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: 8 hours post infusion
Investigator Hemostatic Efficacy Assessment 24 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: 24 hours post infusion
Number of Participants With Factor VIII (FVIII) Inhibitor Development
Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and \<= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received \>100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
Time frame: Day 1 and Month 6 or Early Termination Visit
FVIII Recovery : Change From Baseline in FVIII Concentration
FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.
Time frame: Day 1 and Month 6 or Early Termination Visit
Number of Participants With Less Than Expected Therapeutic Effect (LETE)
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Pfizer Investigational Site
Guangzhou, China
Pfizer Investigational Site
Shanghai, China
The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.
Time frame: 24 hours after each of 2 successive infusion, up to 6 months
Number of Participants With Thrombosis Allergic-Type Reactions
Time frame: Baseline up to 6 months
Number of Participants With Thrombosis
Time frame: Baseline up to 6 months