Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
NCT ID: NCT06142552
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2023-12-27
2026-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prevention and Treatment Group (PPX group)
Subjects received single and multiple doses of 50 IU/kg FRSW117 at first administration of V1 (D1), V4 (18w), and V7 (50w), and PK samples were collected until 168 h post-administration, respectively.
During prophylaxis, FRSW117 is used for breakthrough therapy if the subject has a breakthrough bleeding event (i.e., a bleeding event during prophylaxis) that requires treatment.
FRSW117
once a week, 50 weeks and as needed
On Demand/Preventive Treatment Group (On Demand /PPX Group)
The appropriate dose and frequency of administration of FRSW117 is recommended until bleeding events are controlled or returned to pre-bleeding activity.
FRSW117
once a week, 50 weeks and as needed
Perioperative management
Patients in the PPX and on demand /PPX groups will be allowed to undergo surgery (both major and minor) during the main trial period (prior to 50w), while FRSW117 will be administered perioperatively
FRSW117
once a week, 50 weeks and as needed
Interventions
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FRSW117
once a week, 50 weeks and as needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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 \< 60 g/L);
6. Platelet count during screening period \< 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.
12 Years
65 Years
MALE
No
Sponsors
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Jiangsu Gensciences lnc.
INDUSTRY
Responsible Party
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Principal Investigators
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Renchi Yang
Role: STUDY_CHAIR
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Locations
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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
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, , China
Affiliated Hospital of Jiangnan University
Wuxi, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zhenyu Li
Xuzhou, , China
Subei People's Hospital of Jiangsu province
Yangzhou, , China
Henan Cancer Hospital
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Zhengzhou People's Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Renchi Yang, PhD
Role: CONTACT
Facility Contacts
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Liang Wang
Role: primary
Xielan Zhao
Role: primary
Shifeng Lou
Role: primary
Fenge Yang
Role: primary
Jing Sun
Role: primary
Wenyuan Mai
Role: primary
Xiaoyu Zhu
Role: primary
Yun Chen
Role: primary
Kehong Bi
Role: primary
Zeping Zhou
Role: primary
Yaming Xi
Role: primary
Chenhao Jin
Role: primary
Rongfu Zhou
Role: primary
Hong Liu
Role: primary
Zhongguang Cui
Role: primary
Xuefeng Wang
Role: primary
Lisheng Cai
Role: primary
Ziqiang Yu
Role: primary
Yanping Ma
Role: primary
Zhenyu Yan
Role: primary
Haiying Hua
Role: primary
Bing Xu
Role: primary
Zhenyu Li
Role: primary
Mei Sun
Role: primary
Hu Zhou
Role: primary
Pingchong Lei
Role: primary
Shuxia Guo
Role: primary
Other Identifiers
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SS-117-III01
Identifier Type: -
Identifier Source: org_study_id
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