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NCT07663903Fut, nem toboroz3. fázis

Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment

A Single-arm, Open-label, Multicenter Phase III Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-demand Treatment in Patients With Severe Hemophilia A (Adults and Adolescents) .

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 8.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A. Secondary objectives: Evaluation of the safety and immunogenicity of FRSW107 as an on-demand therapy in previously treated patients with severe hemophilia A. Evaluate the on-demand treatment's PK profile of FRSW107 in previously treated patients with severe hemophilia A based on population pharmacokinetic (PopPK) methods ; preliminarily investigate the exposure-response (E-R) relationship of FRSW107 on-demand treatment in these patients if data permit.

Állapot (regiszter)
Fut, nem toboroz
Fázis (regiszter)
3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
60 (tervezett)
Első benyújtás
2026. jún. 15.
Kezdés
2026. ápr. 14.
Elsődleges befejezés
2027. febr.
Fő szponzor
Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Betegségek
Hemofília
NCT-szám
NCT07663903

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 3. fázis
  • Tervezett résztvevők: 60
  • 2026. ápr. 14. és az elsődleges befejezés (2027. febr.) között
  • 24 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Known or suspected allergy to the investigational drug or its excipients, including mouse or hamster proteins;
  • 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;
  • 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);

Más betegség

  • 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;
  • 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);
  • 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;
  • Have other serious medical conditions that the researchers said could not benefit from them

Laborértékek

  • 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); or Serum creatinine (Cr) >1.5x ULN;
  • 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.

Egyéb

  • Von Willebrand factor (vWF) antigen test results were lower than the lower limit of normal value;
  • Patients with coagulation dysfunction other than hemophilia A;
  • 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.);
  • Subjects deemed unsuitable by other investigators.

A regiszterben nem jelölt feltételek

  • Inclusive Criteria:
  • Males aged 12 or younger to 65 years old.
  • Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity < 1%.
  • Previous records confirm receipt of any recombinant and/or blood-derived coagulation factor VIII products or cold precipitate products, with a treatment of ≥150 exposure days (EDs ≥150).
  • The participants have fully understood and been informed of this study, signed the informed consent form, and voluntarily enrolled in the clinical trial. The trial participants and/or their guardians are capable of cooperating with the hemostatic treatment and have the ability to complete all study procedures.

Életkor a regiszterben: 12 év – 65 év · Nem: csak férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (24)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Fuyang Hospital Affiliated to Anhui Medical UniversityFuyangKínaIsmeretlen állapot
Fujian Medical University Union HospitalFuzhouKínaIsmeretlen állapot
Ganzhou People's HospitalGanzhouKínaIsmeretlen állapot
Nanfang Hospital of Southern Medical UniversityGuangzhouKínaIsmeretlen állapot
Anhui Provincial HospitalHefeiKínaIsmeretlen állapot
Huai'an Second People's HospitalHuai'anKínaIsmeretlen állapot
Jinan Central HospitalJinanKínaIsmeretlen állapot
The Second Affiliated Hospital of Kunming Medical UniversityKunmingKínaIsmeretlen állapot
The First Affiliated Hospital of Guangxi Medical UniversityNanningKínaIsmeretlen állapot
Affiliated Hospital of Nantong UniversityNantongKínaIsmeretlen állapot
The First Affiliated Hospital of Nanyang Medical CollegeNanyangKínaIsmeretlen állapot
Qinghai Provincial People's HospitalQinghaiKínaIsmeretlen állapot
Rizhao People's HospitalRizhaoKínaIsmeretlen állapot
The Second Hospital of Hebei Medical UniversityShijiazhuangKínaIsmeretlen állapot
The Second Hospital of Shanxi Medical UniversityTaiyuanKínaIsmeretlen állapot
North China University of Science and Technology Affiliated HospitalTangshanKínaIsmeretlen állapot
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjinKínaIsmeretlen állapot
Wenzhou People's HospitalWenzhouKínaIsmeretlen állapot
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyWuhanKínaIsmeretlen állapot
Affiliated Hospital of Jiangnan UniversityWuxiKínaIsmeretlen állapot
Xi'an Central HospitalXi’anKínaIsmeretlen állapot
Subei People's Hospital of Jiangsu provinceYangzhouKínaIsmeretlen állapot
Zhengzhou People's HospitalZhengzhouKínaIsmeretlen állapot
Henan Cancer HospitalZhengzhouKínaIsmeretlen állapot

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