Clinical trial: Efficacy and Safety Study of SCT800 for On-demand Treatment With in Patients With Hemophilia A (NCT02921945)

Eligibility criteria:
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;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment