Hemophilia A
Conditions
Interventions
Group S1:The subjects were first given a single dose of the control drug Perinez, and then given a single dose of recombinant human coagulation factor VIII-Fc fusion protein for low-dose injection
Group S2:Patients will be administered a single dose of ADVATE and a single dose of PEGylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (medium dose)
Group S3:Patients will be administered a single dose of ADVATE and a single dose of PEGylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (high dose)
Sponsors
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males aged >= 12 and = 150); 3. Non-immune deficiencies, with certain immunity (CD4 > 200/µL); 4. Platelet count > 100 x 10^9 /L; 5. The prothrombin time (PT) is normal or the international normalized ratio (INR) is less than 1.3; 6. Lupus anticoagulant is negative; 7. Fully understand and know this study and sign an informed consent form, voluntarily participate in clinical research and have the ability to complete all research procedures.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the test product or its auxiliary materials (including rodent or hamster protein); 2. Previous hypersensitivity or allergic reactions after FVIII or IgG2 injection treatment; 3. FVIII inhibitors are positive at the time of screening (>=0.6 BU/mL), or have a history of positive FVIII inhibitors in the past, or have a history of inhibitors in the family; 4. In addition to hemophilia A, there are patients with other blood coagulation disorders; 5. The test result of von Willebrand factor (vWF) antigen is lower than normal; 6. Severe anemia and need blood transfusion (hemoglobin = grade III), severe arrhythmia, and inability occurred within 6 months before medication Controlled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 95 mmHg), etc.; 12. Those who have a history of drugs or alcoholism in the past; 13. Suffer from known mental disorders that may affect test compliance; 14. Patients with abnormal liver function: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST)> 2 times the upper limit of normal (ULN); (2) Serum bilirubin (TBIL) > 2 x ULN; 15. People with abnormal renal function: (1) Urea nitrogen (BUN) > 2 x ULN; (2) Serum creatinine (Cr) > 176.8 µmol/L; 16. Those who have one or more of the tests for hepatitis B virus surface antigen, anti-human immunodeficiency virus antibody (HIV), anti-Treponema pallidum specific antibody (TPHA), and hepatitis C virus (HCV) antibody tests have clinical significance; 17. Patients who have used any anticoagulation or antiplatelet drug treatment within 7 days before screening or who need to use anticoagulation or antiplatelet drug treatment during clinical trials; 18. Within 14 days before medication or planned to use systemic immunomodulators (such as corticosteroid drugs [>10 mg/day equivalent dose of prednisone], interferon alpha, immunoglobulin, cyclophosphamide, Cyclosporine, etc.); 19. Those who have undergone major surgery and blood or blood component transfusions within 4 weeks before screening, or who plan to undergo surgery during the study period; 20. Those who have participated in other clinical trials within 1 month before screening; 21. Those who have a birth plan or sperm donation plan during the entire trial period to 3 months after the last medication, or who are unwilling to take effective physical contraceptive measures (such as condoms, diaphragms, intrauterine devices, etc.); 22. Those who suffer from other serious diseases that the researcher thinks cannot benefit from them; 23. Subjects judged by other researchers to be unsuitab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Virology;Virology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events/Adverse Drug Reaction;Levels of anti-PEG-RF VIIIFc antibodies;Level of anti-PEG antibody;F? Inhibitor detection;Allergic reactions;Bleeding events;Laboratory tests: blood routine, urine routine, blood biochemical;Blood coagulation function;Thrombosis marker;12- lead electrocardiogram;Physical examination: Sitting blood pressure, underarm temperature, pulse, and respiration;Vital signs; | — |
Countries
China
Contacts
Public ContactYang Renchi
Hematology Hospital of Chinese Academy of Medical Sciences
Outcome results
None listed