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New treatment option for Severe Hemophilia A
Official title Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein
ClinicalTrials.gov ID: NCT06142552
What this study is testing
What is FRSW117?
FRSW117 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for severe hemophilia a.
Also referred to as Recombinant human coagulation factor Ⅷ-Fc fusion protein for injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65, men only
You may be able to join if
- 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...
- Previous documented treatment with any recombinant and/or blood-derived coagulation factor Ⅷ products or cryoprecipitation products and dosed ≥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...
You likely can't join 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...
- 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;
See the full eligibility 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...
- 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) \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 people 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
- people deemed unsuitable by other investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Jinan, China
- Kunming, China
- Lanzhou, China
- Nanchang, China
- Nanjing, China
- Nantong, China
- Qingdao, China
- Shanghai, China
- Shenzhen, China
- Suzhou, China
- Taiyuan, China
- Tangshan, China
- Tianjin, China
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Chongqing, China; Fuzhou, China; Guangzhou, China; Hangzhou, China and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.