Phase 3 Haemophilia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Male patients diagnosed with severe hemophilia A, meaning their Factor VIII levels are less than 1% as confirmed by a central laboratory test
• Patients who have never previously been treated with plasma-derived or recombinant Factor VIII products, including a product called SCT800 (patients who have received 5 or fewer doses of blood products such as cryoprecipitate or fresh frozen plasma may still be considered)
• Patients who do not have FVIII inhibitors (antibodies that block Factor VIII from working)
• Patients who have provided informed consent to participate in the trial

Who may not be able to join:

• Patients with a known allergy to recombinant clotting Factor VIII products or any of their ingredients, or known allergies to bovine (cattle), rodent, or hamster-derived materials
• Patients who have a personal or family history of developing inhibitors (blocking antibodies) against Factor VIII
• Patients whose liver function test results (specific markers called ALT and AST) are 5 or more times above the normal range, or whose kidney function test results (specific markers called BUN and creatinine) are 2 or more times above the normal range
• Patients who have another blood clotting disorder in addition to hemophilia A
• Patients whose INR (a standard blood clotting measurement) is above 1.5 (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.