Safety and Efficacy of Long-term Treatment With SCT800 in Previously Treated Hemophilia A Patients.

NCT ID: NCT03947567

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-26
• Study Completion Date: 2025-04-01

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.

Conditions

Hemophilia A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Recombinant Human Coagulation FVIII

Group Type: EXPERIMENTAL

Recombinant Human Coagulation FVIII

Intervention Type: DRUG

Participants received SCT800 for prophylaxis and/or on-demand treatment for 120 weeks.

Interventions

Recombinant Human Coagulation FVIII

Participants received SCT800 for prophylaxis and/or on-demand treatment for 120 weeks.

Intervention Type: DRUG

Other Intervention Names

SCT800

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;

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renchi Yang

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Renchi Yang

Role: CONTACT

rcyang65@163.com

13512078851

Feng Xu

Role: CONTACT

Facility Contacts

Renchi Yang

Role: primary

Other Identifiers

SCT800-A401

Identifier Type: -

Identifier Source: org_study_id