Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A

This is an interventional treatment trial for Hemophilia A Read More

Inclusion Criteria:

• 12 to 65 years old;
• The activity of the coagulation factor VIII (FVIII:C) ≤5%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
• Bleeding state need to be treated with FVIII;
• Negative assays for FVIII inhibitors (<0.6 BU/mL);
• The platelet count is normal；
• Normal prothrombin time or INR ≤1.5；
• Given informed consent

Exclusion Criteria:

• Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
• Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
• Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII], cryoprecipitate and whole blood);
• Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
• HIV seropositive;
• Abnormal hemostasis from causes other than hemophilia A；
• Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
• Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
• Alcoholism, drug abuse, mental disorders and mental retardation;
• Elective surgery planned during the process of study;
• Patients who previously participated in the other clinical trials prior to study entry;
• The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
• Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;