The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A. Secondary objectives: Evaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A. Evaluate the on-demand treatment's PK profile of FRSW107 in previously treated patients with severe hemophilia A based on population pharmacokinetic (PopPK) methods ; preliminarily investigate the exposure-response (E-R) relationship of FRSW107 on-demand treatment in these patients if data permit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Treatment for 6 months as needed.
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Fuyang Hospital, Affiliated to Anhui Medical University
Fuyang, China
Fujian Medical University Union Hospital
Fuzhou, China
Ganzhou People's Hospital
Ganzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
Anhui Provincial Hospital
Hefei, China
Huai'an Second People's Hospital
Huai'an, China
Jinan central hospital
Jinan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
...and 14 more locations
The haemostatic effective rate
The haemostatic effect of FRSW107 when used for treatment of bleeds, assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) by counting excellent and good as success and moderate and none as failure.
Time frame: 6 months
Number of infusions and IU/kg of FRSW107 needed for the treatment of bleeding episodes
Time frame: 6 months
FVIII activity during on-demand: activity recovery rate
FVIII activity recovery rate on Day1's haemostatic therapy.
Time frame: Visit1,Day1
Hemophilia Joint Health Score (HJHS 2.1) during on-demand treatment
total score and each subscale score of HJHS 2.1, as well as their changes over time.
Time frame: 6 month
incidence of lack of drug efficacy
Lack of drug efficacy is defined as: during on-demand treatment, hemostatic efficacy is assessed as "ineffective" or "poor/no response" following two consecutive administrations within 72 hours for the same bleeding episode. incidence of lack of drug efficacy=number of lack of drug efficacy/number of evaluated treatment\*100%.
Time frame: 6 months
Occurrence of AEs and SAEs
Time frame: 6 month
Incidence rate of positive FVIII inhibitors
A positive FⅧ inhibitor is defined as a Bethesda inhibitor titer ≥ 0.6 BU/mL. Incidence rate of positive FVIII inhibitors=number of positive FⅧ inhibitors participant / total number of trial participants \*100%.
Time frame: 6 month
Incidence rate of positive ADA, Incidence rate of positive anti-CHO antibody
Incidence rate of positive ADA=number of positive ADA participant / total number of trial participants \*100% Incidence rate of positive anti-CHO antibody=number of positive anti-CHO antibody participant / total number of trial participants \*100%
Time frame: 6 month
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