Status:
COMPLETED
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
Lead Sponsor:
Sinocelltech Ltd.
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Parexel
Conditions:
Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
Brief Summary
This study is a multi-center, open-label, single-arm trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (≥12 years old)...
Detailed Description
After subjects pass screening, prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week for 6 months. Subjects shall receive FVIII intravenous inject...
Eligibility Criteria
Inclusion
- Aged ≥12 years old and ≤65 years old;
- Male patients who are clinically diagnosed with severe (laboratory tested FVIII:C \<1%) hemophilia A, including historical FVIII:C \<1%;
- Previously received FVIII treatment (prophylactic or bleeding treatment), have the relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
- The bleeding treatment records of at least 3 months before screening can be obtained;
- Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay result \<0.6 BU(Bethesda unit)/mL);
- The prothrombin time is normal or international normalized ratio (INR) ≤1.5; 7. Platelet count ≥100 × 109/L;
Exclusion
- Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;
- Has a history or family history of blood coagulation factor VIII inhibitor;
- Clinical liver function test (glutamic-pyruvic transaminase, glutamic-pyruvic transaminase) ≥ three times the upper limit of normal (ULN) or clinical kidney function test (blood urea nitrogen, creatinine) ≥ three times the ULN;
- Patients clinically diagnosed with active Hepatitis B or Hepatitis C;
- Patients with other coagulation dysfunction diseases in addition to hemophilia A;
- Patients with severe heart disease, including myocardial infarction and cardiac dysfunction of class III or above;
- Patients who previously experienced intracranial bleeding;
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03815318
Start Date
January 21 2019
End Date
January 16 2020
Last Update
February 6 2020
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China