A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
- Registration Number
- NCT05265286
- Lead Sponsor
- Jiangsu Gensciences lnc.
- Brief Summary
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- The activity of the coagulation factor VIII (FVIII:C) < 1%.
- 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
- 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.• Significant hepatic or renal impairment (ALT and AST > 2×ULN; serum bilirubin level > 2 × upper limit of normal (ULN), Urea /BUN > 2×ULN, Cr > 176.8 µmol/L)
- 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 screening
- 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
Other protocol-defined inclusion/exclusion Criteria May Apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 prophylaxis treatment FRSW117 Subjects of high dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. Subjects of low dose group are being received four doses of FRSW117. dosing on day1(ED1), day8(ED2), day15(ED3), day22(ED4) respectively. All subjects are being received PK assessment in ED1 and ED4.
- Primary Outcome Measures
Name Time Method Time required for the concentration of the drug to reach half of its original value (T1/2) Pre-dose and post dose up to 10 days Measured by One-Stage Clotting Assay
Maximum measured concentration of FVIII:C (Cmax) Pre-dose and post dose up to 10 days Measured by One-Stage Clotting Assay
Area Under the Curve to Infinity (AUC) Pre-dose and post dose up to 10 days Measured by One-Stage Clotting Assay
Evaluation of the level of anti-PEG antibody production in participants Pre-dose and post dose up to 36 days Evaluation of the level of anti-PEG-rFⅧFc antibody production in participants Pre-dose and post dose up to 36 days The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time (CL) Pre-dose and post dose up to 10 days Measured by One-Stage Clotting Assay
- Secondary Outcome Measures
Name Time Method score of bleeding symptoms and Vital signs Pre-dose and post dose up to 36 days Response to treatment with PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for bleeding episodes, using the 4-point bleeding response scale
Number of participants with treatment-related adverse events as assessed by CTCAE V5.0 Pre-dose and post dose up to 36 days Adverse events related to PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein according to Common Terminology Criteria for Adverse Events (CTCAE) NCI.V5.0.
Development of Inhibitor Pre-dose and post dose up to 36 days Measured by the Nijmegen-Modified Bethesda Assay
Trial Locations
- Locations (5)
People'S Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
People'S Hospital of Rizhao
🇨🇳Rizhao, Shandong, China
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
🇨🇳Tianjin, Tianjin, China