Brief Title
Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.
Official Title
A Multicenter, Open, Extension Trial to Evaluate Safety and Efficacy of Recombinant Human Coagulation Factor VIII (SCT800) During Long Term Treatment in Previously Treated Patients With Severe Haemophilia A .
Brief Summary
This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of
SCT800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia A
who have been previously treated with coagulation factor VIII(FVIII) . This study includes
two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of
SCT800 shall be administered once every other day or three times per week starting from V1,
on-demand treatment is given when bleeding episodes occur. The study period is 120
consecutive weeks.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Incidence of FVIII inhibitors
Secondary Outcome
Annualized Bleeding Rate
Condition
Hemophilia A
Intervention
Recombinant Human Coagulation FVIII
Study Arms / Comparison Groups
Recombinant Human Coagulation FVIII
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
240
Start Date
July 26, 2019
Completion Date
April 1, 2025
Primary Completion Date
April 1, 2025
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;
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Renchi Yang, 13512078851, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03947567
Organization ID
SCT800-A401
Responsible Party
Sponsor
Study Sponsor
Sinocelltech Ltd.
Study Sponsor
Renchi Yang, Principal Investigator, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Verification Date
May 2019