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:

• Men between the ages of 12 and 65 years old
• People who have been clinically confirmed to have severe hemophilia A, meaning their Factor VIII activity level is less than 1% (confirmed by lab testing or past medical records)
• People who have previously been treated with recombinant or blood-derived Factor VIII products, or cryoprecipitation products, for at least 150 treatment days
• People whose blood clotting time (prothrombin time or INR) is within a normal or near-normal range (INR below 1.3)
• People who have kept detailed records of their bleeding episodes for at least 6 months before joining the trial (those in the on-demand or preventive treatment group must have had at least 6 spontaneous bleeding episodes in that 6-month period)
• People who fully understand the study, are willing to sign a consent form, and are able to carry out bleeding treatment at home and complete all study requirements (a guardian may assist if needed)

Who may not be able to join:

• People with a known or suspected allergy to the study drug or its ingredients, including proteins derived from mice or hamsters
• People who have had a severe allergic reaction to Factor VIII or a type of antibody called IgG2 in the past
• People who test positive for Factor VIII inhibitors (antibodies that block Factor VIII) at or above a certain level during screening, or who have a personal or family history of such inhibitors
• People whose Von Willebrand factor (a protein that helps blood clot) test results are below the normal range
• People with severe anaemia (very low red blood cell levels, specifically haemoglobin below 60 g/L) at the time of screening
• People with a low platelet count (below 100×10⁹/L) during the screening period
• People with abnormal liver function, including elevated liver enzymes (ALT or AST more than 3 times the upper limit of normal) or elevated bilirubin (more than 1.5 times the upper limit of normal)
• People with abnormal kidney function, based on creatinine clearance or serum creatinine levels being outside acceptable ranges
• People with active hepatitis C (both HCV antibody and HCV RNA positive), a positive test for syphilis-related antibodies, or a positive HIV antibody test
• People who have a blood clotting disorder other than hemophilia A
• People who have a medical condition that may increase the risk of bleeding
• People with a history of drug or alcohol abuse
• People with a known mental health condition that may affect their ability to follow the trial requirements
• People who received a blood or blood component transfusion within 4 weeks before screening
• People who participated in another clinical trial within 1 month before screening
• People who used blood-thinning medications (anticoagulants), antiplatelet drugs, or non-steroidal anti-inflammatory drugs (NSAIDs) at above-label doses within 7 days before screening, or who would need to use these during the trial
• People with serious heart or blood vessel conditions, such as stroke, heart attack, unstable chest pain, significant heart failure, severe heart rhythm problems, uncontrolled high blood pressure, or deep vein thrombosis (blood clots in veins)
• People who used a medication called emicizumab within 6 months before the first dose of the study drug
• People who used certain types of antibody-based therapies, fusion protein products (with specific exceptions), PEG-based products (with specific exceptions), or intravenous immunoglobulin within 3 months before the first dose
• People who had major surgery within 3 months before the first dose (confirm with trial site for the definition of major surgery)
• People who used standard half-life Factor VIII products within 3 days or 5 half-lives before the first dose, or extended half-life Factor VIII products within 4 days or 5 half-lives before the first dose
• People who had a fever, serious active bacterial or viral infection, or allergic reaction within 2 weeks before the first dose
• People who used systemic immune-suppressing or immune-modifying medications (such as high-dose steroids, interferon, or similar drugs) within 14 days before the first dose or who plan to use them during the trial (inhaled, nasal spray, or topical corticosteroids are generally allowed — confirm with trial site)
• People who received a vaccination within 4 weeks before the first dose, or who plan to be vaccinated during a specific blood-collection phase of the trial (applies to a subgroup of participants — confirm with trial site)
• People who plan to conceive a child or donate sperm during the trial or within 3 months after the last dose, or who are unwilling to use effective physical contraception (such as condoms, diaphragms, or IUDs)
• People with other serious medical conditions that the researchers consider would prevent them from benefiting from participation
• People considered unsuitable for any other reason by the researchers

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