Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

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

Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetics of Recombinant Human Coagulation Factor Ⅷ-Fc Fusion Protein (FRSW117) for Injection in Patients With Severe Hemophilia A (Adults and Adolescents)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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 Who Should NOT Join This Trial: 1. Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins; 2. Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past; 3. 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; 4. Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value; 5. Severe anemia at the screening stage (hemoglobin \&lt; 60 g/L); 6. Platelet count during screening period \&lt; 100×109 /L; 7. 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; 8. Patients with abnormal renal function: Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); orSerum creatinine (Cr) \>1.5x ULN; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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: 1. Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins; 2. Hypersensitivity or anaphylaxis after FⅧ or IgG2 injection in the past; 3. 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; 4. Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value; 5. Severe anemia at the screening stage (hemoglobin \&lt; 60 g/L); 6. Platelet count during screening period \&lt; 100×109 /L; 7. 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; 8. Patients with abnormal renal function: Creatinine clearance (Ccr) \<50 ml/min (according to Cockcroft and Gault formula); orSerum creatinine (Cr) \>1.5x ULN; 9. 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); 10. Patients with coagulation dysfunction other than hemophilia A; 11. Have a medical condition that may increase the risk of bleeding; 12. A history of drug or alcohol abuse; 13. Have a known mental disorder that may affect trial compliance; 14. Patients who have received transfusions of blood or blood components within 4 weeks prior to screening; 15. Participants who had participated in other clinical trials within 1 month before screening; 16. 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; 17. 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. 18. Study patients who had used emesezumab within 6 months prior to first administration of the drug; 19. 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; 20. Study patients who underwent major surgery within 3 months prior to initial drug administration (major surgery is defined in 6.2.3 Perioperative management); 21. 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); 22. Study patients with fever, severe active bacterial or viral infection, and allergies within 2 weeks before the first administration of the drug; 23. 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; 24. 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); 25. 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.); 26. Have other serious medical conditions that the researchers said could not benefit from them 27. Subjects deemed unsuitable by other investigators.

Treatments Being Tested

DRUG

FRSW117

once a week, 50 weeks and as needed

Locations (20)

Beijing tongren hospital,CMU
Beijing, China
XiangYa Hospital CentralSouth University
Changsha, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, China
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
Jinan central hospital
Jinan, China
The First Affiliated Hospital of Shandong First Medical University
Jinan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
The First Hospital of Lanzhou University
Lanzhou, China
Jiangxi Provincial People's Hospital
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
Affiliated Hospital of Nantong University
Nantong, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, China
Shenzhen Second People's Hospital
Shenzhen, China
The First Affiliated Hospital of Soochow University
Suzhou, China
The Second Hospital of Shanxi Medical University
Taiyuan, China
North China University of Science and Technology Affiliated Hospital
Tangshan, China