To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A. To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A. To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
once a week, 50 weeks and as needed
Beijing tongren hospital,CMU
Beijing, China
RECRUITINGXiangYa Hospital CentralSouth University
Changsha, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, China
ABR
Annual rate of bleeding (ABR) during preventive treatment = Number of bleeding during the efficacy evaluation period/(number of treatment days /365.25)
Time frame: 1year
Effective rate of bleeding treatment
The hemostatic effect was evaluated according to a four-level scoring scale, including breakthrough bleeding treatment during preventive treatment and on-demand treatment during on-demand treatment
Time frame: 2year
Safety evaluation
Incidence of positive FⅧ inhibitor. Adverse events/Adverse events: Adverse events during treatment (TEAE), serious Adverse events (SAEs), adverse events of particular concern (AESI), occurrences of adverse events that cause subjects to discontinue medication, drop out of the study, and death, and occurrences of the above metrics associated with the investigational drug. Injection site reaction. Laboratory tests: blood routine, urine routine, blood biochemistry, coagulation function, virology and immune function tests. Thrombosis markers. Vital signs, physical examination, neurological examination, 12-lead electrocardiogram, surgery-related complications. PEG level.
Time frame: 3year
Adverse events/reactions
Adverse events during treatment (TEAE), serious Adverse events (SAEs), with a special focus on adverse events (AESI), adverse events that cause subjects to discontinue medication, drop out of the study, and die, etc.
Time frame: ALL
Immunogenicity evaluation
The positive rate of anti-FRSW117 antibody, anti-PEG antibody and anti-CHO antibody; When the anti-FRSW117 antibody was positive, the anti-RHFVIII antibody and anti-PEG antibody were further detected to evaluate the positive incidence
Time frame: ALL
Renchi Yang, PhD
CONTACT
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Nanfang Hospital of Southern Medical University
Guangzhou, China
RECRUITINGThe First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, China
NOT_YET_RECRUITINGAnhui Provincial Hospital
Hefei, China
RECRUITINGJinan central hospital
Jinan, China
RECRUITINGThe First Affiliated Hospital of Shandong First Medical University
Jinan, China
RECRUITINGThe Second Affiliated Hospital of Kunming Medical University
Kunming, China
RECRUITING...and 18 more locations