Hemophilia A
Conditions
Interventions
Group S1:Patients will be administered a single dose of ADVATE and a single dose of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection (low dose).
Group S2:Patients will be administered a single dose of ADVATE and a single dose of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection (high dose).
Sponsors
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
Male
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: (1) Aged 12 years to 60 years male; (2) The activity of the coagulation factor VIII (FVIII:C) 200/µL ; (4) Non-acute hemorrhagic state; (5) No history of a positive inhibitor test ( 100,000 platelets/µL; (7) Normal prothrombin time or INR < 1.3; (8) Normal thrombin time (TT); (9) Normal previous results of vWF antigen examination; (10) Negative lupus anticoagulant; (11) Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: (1) Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins); (2) History of hypersensitivity or anaphylaxis associated with any FVIII or IgG2 administration; (3) Current FVIII inhibitor-positive or history of FVIII inhibitor-positive; (4) Other coagulation disorder(s) in addition to hemophilia A; (5) Infusion of any products containing FVIII within 4 days prior screening or within 72 h prior to administration; (6) Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level); (7) Clinically significant of other systematic diseases: alcoholism, drug abuse,mental disorders and mental retardation; (8) Significant hepatic or renal impairment (ALT and AST > 2xULN; serum bilirubin level > 3 x upper limit of normal (ULN), BUN > 2xULN, Cr > 2.0mg/dL); (9) One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody; (10) Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials; (11) Patients having major surgery or receiving blood or blood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study; (12) Patients who previously participated in the other clinical trials within 1 month prior screening; (13) Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation; (14) Patient who is considered by the other investigators not suitable for clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Clinical laboratory examination;EGG;The inhibitor titre course;Adverse Drug Reaction; | — |
Countries
China
Contacts
Public ContactRenchi Yang
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed