Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein

Recruiting now · Phase 3

Conditions studied: Severe Hemophilia A

In brief

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 human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein for injection (FRSW117) in hemostasis and surgical hemostasis in patients with severe hemophilia A. To evaluate the pharmacokinetic (PK) characteristics of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A. To evaluate the immunogenicity of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in treated patients with severe hemophilia A.

Key facts

Study ID

NCT06142552

Run by

Hangzhou Gensciences Biopharmaceutical Co., Ltd.

People needed

120

Starts

2023-12-27

Expected to finish

2026-09-01

Last updated by the study team

2024-02-28

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• 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;

Where it is running

• Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, China (enrolling)
• Affiliated Hospital of Jiangnan University — Wuxi, China (enrolling)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (enrolling)
• Anhui Provincial Hospital — Hefei, China (enrolling)
• Subei People's Hospital of Jiangsu province — Yangzhou, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, China (enrolling)
• Jinan central hospital — Jinan, China (enrolling)
• Beijing tongren hospital,CMU — Beijing, China (enrolling)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, China (enrolling)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, China (enrolling)
• The First Hospital of Lanzhou University — Lanzhou, China (enrolling)
• Jiangxi Provincial People's Hospital — Nanchang, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, China (enrolling)
• Affiliated Hospital of Nantong University — Nantong, China (enrolling)
• Nanfang Hospital of Southern Medical University — Guangzhou, China (enrolling)
• XiangYa Hospital CentralSouth University — Changsha, China (enrolling)
• Shenzhen Second People's Hospital — Shenzhen, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, China (enrolling)
• The Second Hospital of Shanxi Medical University — Taiyuan, China (enrolling)
• North China University of Science and Technology Affiliated Hospital — Tangshan, China (enrolling)
• Zhengzhou People's Hospital — Zhengzhou, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China
• The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou, China
• Nanjing Drum Tower Hospital — Nanjing, China
• The Affiliated Hospital of Qingdao University — Qingdao, China

Full record on ClinicalTrials.gov

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