Status:
COMPLETED
A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection
Lead Sponsor:
Jiangsu Gensciences lnc.
Conditions:
Hemophilia A
Eligibility:
MALE
Up to 12 years
Phase:
PHASE1
Brief Summary
Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII, Fc Fusion Protein for Injection (FRSW107) Secondary objectives: To assess Safety and Tolerability by mon...
Eligibility Criteria
Inclusion
- Key
- The activity of the coagulation factor VIII (FVIII:C) \< 1%. Less than 6 years old Patients previously treated with FVIII concentrate (s) for a minimum of 50 exposure days (EDs) prior to study entry. 6 years old to 12 years old Patients previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
- Normal prothrombin time or INR \< 1.3.
- Negative lupus anticoagulant.
- Key
Exclusion
- Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
- History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
- Current FVIII inhibitor-positive or history of FVIII inhibitor-positive.
- Other coagulation disorder(s) in addition to hemophilia A.
- Infusion of any products containing FVIII within 72 h prior to administration.
- Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 2 × upper limit of normal (ULN), BUN \> 2×ULN, Cr \> 2.0 ULN).
- One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
- Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
- Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
- Patients who previously participated in the other clinical trials within one month prior to administration.
- Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
- Patient who is considered by the other investigators not suitable for clinical study.
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05251090
Start Date
June 16 2021
End Date
May 9 2022
Last Update
August 22 2023
Active Locations (6)
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1
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Shenzhen Children's Hospita
Shenzhen, Guangdong, China, 518000
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China, 510515
4
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430000