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:

• You are male and between 12 years old or younger and up to 65 years old
• You have been clinically diagnosed with severe hemophilia A, confirmed by a test showing your Factor VIII activity level is less than 1%
• You have previously been treated with clotting factor VIII products (recombinant or blood-derived) or cold precipitate products on at least 150 separate occasions
• You fully understand the study, have signed a consent form, and are willing and able to follow all study procedures (a parent or guardian may sign on behalf of a child)

Who may not be able to join:

• You have a known or suspected allergy to the study drug or its ingredients, including proteins derived from mice or hamsters
• You have had a severe allergic reaction to Factor VIII or a type of antibody product called IgG2 in the past
• You have developed antibodies that work against Factor VIII (called "inhibitors") currently, in the past, or if this runs in your family
• Your von Willebrand factor (a protein that helps blood clot) is below the normal range (confirm with trial site)
• You have severe anaemia (very low red blood cell levels) at the time of screening
• Your platelet count (cells that help blood clot) is too low at the time of screening
• Your liver function tests are significantly higher than normal
• Your kidney function is below a certain level
• You currently have active hepatitis C, syphilis, or HIV
• You have another condition that affects how your blood clots, other than hemophilia A
• You have a medical condition that may increase your risk of bleeding
• You have a history of drug or alcohol abuse
• You have a known mental health condition that might make it difficult to follow the trial rules
• You have received a blood transfusion or blood products within 4 weeks before screening
• You have taken part in another clinical trial within 1 month before screening
• You have taken blood thinners, antiplatelet drugs, or high-dose anti-inflammatory medicines (NSAIDs) within 7 days before screening, or you will need to take these during the trial
• You have serious heart or blood vessel disease, or have had a stroke, heart attack, severe heart failure, serious irregular heartbeat, uncontrolled high blood pressure, or blood clots
• You have used a medication called emicizumab within 6 months before the start of the trial
• You have used certain antibody-based therapies, special protein products, or intravenous immunoglobulin within 3 months before the start of the trial
• You have had major surgery within 3 months before the start of the trial
• You have used certain standard or extended Factor VIII products within a few days before the first dose (the exact timeframe depends on the product — confirm with trial site)
• You have had a fever, serious infection, or allergic reaction within 2 weeks before the first dose
• You have used immune-suppressing medications (such as steroids above a certain dose, interferon, or similar drugs) within 14 days before the first dose, or plan to use them during the trial (inhaled or topical versions may be allowed — confirm with trial site)
• You have received a vaccine within 4 weeks before the first dose, or plan to be vaccinated during a specific blood-testing phase of the trial (if you are in the pharmacokinetics subgroup — confirm with trial site)
• You plan to father a child or donate sperm during the trial or within 3 months after your last dose, or you are unwilling to use a reliable physical form of contraception (such as condoms, diaphragms, or IUDs)
• You have another serious medical condition that the researchers believe would prevent you from benefiting from the trial
• The trial investigators have another reason they consider you unsuitable for the study

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