Phase 4 Haemophilia Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with moderate to severe hemophilia A, meaning your body produces 5% or less of the normal level of the clotting protein Factor VIII.
• You are 12 years old or older at the time you give your consent to join.
• At least one of your joints (such as a knee, ankle, or elbow) shows signs of joint lining swelling (synovitis), as measured by a specific ultrasound scoring system called HEAD-US.
• At least one of those affected joints has not had major joint surgery in the past 3 months and has none planned in the future (for example, surgical or chemical procedures to remove the inflamed joint lining).
• You have been receiving regular preventive (prophylactic) treatment for hemophilia A for at least the 12 months before joining the study.
• You are able to understand and sign the consent form and agree to follow the study rules.
• If you are male, no birth control measures are required for this study.
• If you are female and could become pregnant, you agree to use a highly effective form of birth control (with less than 1% chance of failure) throughout the treatment period, and you have a negative pregnancy test at your first study visit.
• If you are female and cannot become pregnant, you may also be eligible.

Who may not be able to join:

• You have another clotting disorder in addition to hemophilia A.
• You are already being treated with the study drug, efanesoctocog alfa.
• You currently have antibodies (called inhibitors) that block Factor VIII from working, at a level of 0.60 BU/mL or higher.
• You have undergone immune tolerance induction (ITI) therapy — a specific treatment to remove inhibitors — within the last 2 years (confirm with trial site).
• You are currently taking part in another clinical trial or have taken an experimental drug within the 3 months before joining this study.
• You are currently in prison or in a legally ordered institution.
• The study doctor believes, for any medical or other reason, that it would not be appropriate or safe for you to participate.
• You are an employee or close family member of someone working at the study site.
• There is any situation in your circumstances that could raise ethical concerns about your participation (confirm with trial site).
• You have had a serious allergic reaction to efanesoctocog alfa or any of its ingredients.

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