Status:
RECRUITING
Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
Lead Sponsor:
Jiangsu Gensciences lnc.
Conditions:
Severe Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
Brief Summary
To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant h...
Eligibility Criteria
Inclusion
- inclusion Criteria：
- 12≤ age ≤65 year-old men;
- Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \< 1%；
- Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥150 exposure days (EDs≥150)
- Normal prothrombin time (PT) or International Normalized Ratio (INR)\<1.3
- Bleeding events were recorded in detail for at least 6 months prior to screening（Participants in the on demand /PPX group were required to have at least 6 episodes of spontaneous bleeding within 6 months）
- Fully understand and know about this study and sign informed consent to participate in the clinical study voluntarily, subject and/or their guardian can cooperate with them for bleeding treatment at home, and have the ability to complete all study procedures
- Exclusion Criteria:
- Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;
- Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past;
- FⅧ inhibitor positive (≥0.6 BU/mL) during the screening period, or have a history of FⅧ inhibitor positive in the past, or a family history of FⅧ inhibitor positive;
- Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;
- Severe anemia at the screening stage (hemoglobin \< 60 g/L);
- Platelet count during screening period \< 100×109 /L;
- Abnormal liver function:
- .Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \>3 times upper limit of normal (ULN); or Serum total bilirubin (TBIL) \>1.5x ULN;
- Patients with abnormal renal function:
- Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); orSerum creatinine (Cr) \>1.5x ULN;
- People with active hepatitis C, that is, hepatitis C virus (HCV) antibody positive and HCV RNA positive; Or anti-treponema pallidum specific antibody (TPHA) positive; Or positive for antibodies against the human immunodeficiency virus (HIV);
- Patients with coagulation dysfunction other than hemophilia A;
- Have a medical condition that may increase the risk of bleeding;
- A history of drug or alcohol abuse;
- Have a known mental disorder that may affect trial compliance;
- Patients who have received transfusions of blood or blood components within 4 weeks prior to screening;
- Participants who had participated in other clinical trials within 1 month before screening;
- Use of any anticoagulant or antiplatelet drugs, off-label maximum dose of non-steroidal anti-inflammatory drugs (NSAID) within 7 days prior to screening; Or patients who need to be treated with anticoagulant or antiplatelet drugs or off-label maximum doses of SAID during clinical trials;
- Severe cardiovascular and cerebrovascular disease or major thromboembolic events, such as stroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association \[NYHA\] grade ≥ III), and severe arrhythmias (including QTc interphase \> 480 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥100 mmHg), deep vein thrombosis, etc.
- Study patients who had used emesezumab within 6 months prior to first administration of the drug;
- Patients who had used monoclonal antibody therapy, Fc fusion protein products (except FRSW107 and FRSW117), PEG products (except FRSW117), or intravenous immunoglobulin infusion within 3 months before the first administration of the investigational drug;
- Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management);
- Study patients who have used FⅧ preparation of any standard half-life (e.g., Bycoch, Coproch, Biinidin, Renjie, NoL, Antaine, etc.) within 3 days or 5 half-lives prior to first administration of the drug (taking the elderly); Patients who have used any other extended half-life preparation FⅧ within 4 days or 5 half-lives prior to first dosing (for the elderly);
- Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug;
- Systemic immunomodulators (such as glucocorticoids \[\> 10 mg/ day equivalent dose of prednisone\], alpha-interferon, immunoglobulin, cyclophosphamide, cyclosporin, etc.) used within 14 days prior to the first administration of the study drug or planned during the study period were allowed to be inhaled, nasal spray, or topical corticosteroids;
- Those who had been vaccinated within 4 weeks prior to initial administration of the study drug; Or who plan to be vaccinated during PK blood collection (only for subjects in the PK subgroup);
- Plan to have a child or sperm donation during the entire trial period and within 3 months after the last dose, or do not want to use effective physical contraception (such as condoms, diaphragms, Iuds, etc.);
- Have other serious medical conditions that the researchers said could not benefit from them
- Subjects deemed unsuitable by other investigators.
Exclusion
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06142552
Start Date
December 27 2023
End Date
September 1 2026
Last Update
February 28 2024
Active Locations (28)
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1
Beijing tongren hospital,CMU
Beijing, China
2
XiangYa Hospital CentralSouth University
Changsha, China
3
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
4
Fujian Medical University Union Hospital
Fuzhou, China