Clinical trial: Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients. (NCT03947567)

Eligibility criteria:
Inclusion Criteria:

          -  Male patients who are diagnosed with severe (laboratory tested FVIII:C <2%) hemophilia
             A;

          -  Patients Who Completed trial of SCT800-A302 or SCT800-A 303 and New PTP(previously
             treated patients)(Previously received FVIII prophylactic or bleeding treatment, have
             the relevant records and are verified to have accumulated exposures days( EDs) ≥150
             days;

          -  Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay
             result <0.6 BU(Bethesda unit)/mL);

          -  The treatment records of at least 50EDs before screening can be obtained;

          -  HIV negative; if HIV positive, the viral load <200 particles/uL or <400,000 copies/mL,
             and HIV patients must satisfy CD4+ count >200/μL;

          -  The patient or his guardian voluntarily signed the Informed Consent Form.

        Exclusion Criteria:

          -  Known allergy to any coagulation factor VIII or any excipient; known allergy to
             bovine, rodent or hamster bovine;

          -  Has a history or family history of blood coagulation factor VIII inhibitor;

          -  Patients with other coagulation dysfunction diseases in addition to hemophilia A;

          -  Patients with other clinically significant diseases, alcoholism, drug abuse, mental
             disorders or intellectual disabilities;

          -  Patients with other severe or clinical significant diseases verified by the
             investigator to be unable to benefit from the clinical study;

          -  Patients who participated in other clinical studies within one month before the first
             drug administration (except FVIII trials) and patients who participated in other FVIII
             clinical trials after signing the Informed Consent Form;
Male
No healthy subjects accepted to join the trial.



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? 0