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 12 and 65 years of age
• People who have been diagnosed with severe hemophilia A, confirmed by blood tests showing clotting factor VIII activity below 1%
• People who have previously been treated with clotting factor VIII products (either lab-made or blood-derived) or cryoprecipitate, with a total of at least 150 treatment days on record
• People whose blood clotting time (PT/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 entering the trial
• People who fully understand the trial, are willing to sign a consent form, and are able (along with their guardian if applicable) to follow the study procedures, including treating bleeds at home

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 products or a type of antibody medication called IgG2 in the past
• People who have, or have ever had, antibodies (inhibitors) against factor VIII, or whose family members have had such inhibitors
• People whose von Willebrand factor levels (a protein that works with factor VIII) are below the normal range
• People with severe anaemia at the time of screening (very low red blood cell levels)
• People with a low platelet count at the time of screening
• People with abnormal liver function test results above certain thresholds
• People with abnormal kidney function based on specific blood and calculation measurements
• People with active hepatitis C, a syphilis-related antibody, or HIV
• People who have a bleeding or clotting disorder other than hemophilia A
• People with a medical condition that may increase their risk of bleeding
• People with a history of drug or alcohol misuse
• People with a known mental health condition that may affect their ability to follow trial requirements
• People who have received a blood transfusion or blood products within 4 weeks before screening
• People who have taken part in another interventional clinical trial within 1 month before screening
• People who have used blood-thinning medications, anti-platelet drugs, or high-dose anti-inflammatory medications (NSAIDs) within 7 days before screening, or who would need such medications during the trial
• People with serious heart or blood vessel conditions, including stroke, heart attack, unstable chest pain, significant heart failure, severe irregular heartbeat, uncontrolled high blood pressure, or blood clots in the veins
• People who have received a medication called emicizumab within 6 months before the first study dose, or who have ever received fitusiran or any gene therapy
• People who have received certain types of antibody-based therapies or intravenous immunoglobulin within 3 months before the first study dose
• People who have had major surgery within 3 months before the first study dose, or who plan to have surgery during the trial
• People who have recently received standard or extended half-life factor VIII products within a specified washout period before the first study dose (confirm exact timeframes with trial site)
• People who have had a fever, serious active infection, or allergic reaction within 2 weeks before the first study dose
• People who have used certain immune-suppressing medications (such as high-dose steroids or chemotherapy-related drugs) within 14 days before the first study dose, or who would need them during the trial (inhaled, nasal, or topical steroids are generally permitted — confirm with trial site)
• People who have received a vaccine within 4 weeks before the first study dose, or who plan to be vaccinated during a specific blood-sampling phase (applies to a subgroup of participants only — confirm with trial site)
• People who plan to father a child or donate sperm during the trial or within 3 months after the last dose, or who are unwilling to use reliable physical contraception (such as condoms, diaphragms, or IUDs)
• People with other serious medical conditions that the trial investigators determine would make participation unsuitable
• People considered unsuitable for the trial by the investigators for any other reason

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