Phase 2 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 must be at least 18 years old at the time of signing the consent form
• You must have been assigned male sex at birth
• You must have severe or moderately severe hemophilia A, meaning your body produces very little or no Factor VIII (3% or less of normal levels), confirmed by a certified lab
• You must have been receiving treatment for hemophilia A for at least 6 months before screening — either as regular preventive Factor VIII infusions, or as on-demand treatment with at least 5 bleeding episodes in the 6 months before screening
• You must have never had a serious allergic reaction (including anaphylaxis) to any Factor VIII product
• You must have received Factor VIII treatment on at least 150 separate occasions in your lifetime
• Your blood test must show no current inhibitors (antibodies that block Factor VIII from working)
• If you previously developed inhibitors but successfully completed immune tolerance therapy at least 5 years ago, and have had no signs of inhibitor return since, you may still be eligible (confirm with trial site)
• Your blood must test negative for antibodies against the study's gene therapy component (Spark200), confirmed by a central laboratory
• Your liver must be functioning well, with normal or near-normal blood enzyme levels, no cirrhosis, and no significant liver disease, as confirmed by blood tests and an ultrasound
• Your kidneys must be functioning adequately (confirmed with trial site), and you must not be on dialysis
• Your platelet count (cells that help blood clot) must be at an acceptable level
• If you are HIV-positive, you must be stable on HIV treatment, with a healthy immune cell count and undetectable virus levels; if you test HIV-negative at screening, you are also eligible
• You must test negative for active hepatitis B infection
• Your hepatitis B antibody and core antibody results must meet certain combinations showing you are not actively infected (confirm with trial site for your specific results)
• You must either test negative for hepatitis C antibodies, or if positive, must have no active hepatitis C virus detected in your blood
• You must be willing and able to attend all study visits, follow the study plan, complete lab tests, and fill out any required questionnaires
• You must agree to follow the contraception requirements described in the study protocol

Who may not be able to join:

• You are currently taking antiviral medication for chronic hepatitis B or hepatitis C
• You have a bleeding disorder other than hemophilia A, whether inherited or developed over time
• You have a condition that causes your blood to clot too easily (a clotting disorder), currently show signs of blood clots, or are being treated for blood clots
• You have previously received any form of gene therapy or gene transfer treatment (note: COVID-19 mRNA vaccines do not count as gene therapy)
• You are currently taking part in another clinical trial, or have taken an experimental drug within the past 30 days or within 5 half-lives of that drug, whichever is longer
• You have a major surgery planned within 15 months after receiving the study treatment
• You are unwilling or unable to receive blood transfusions or standard emergency treatments if needed
• You have any other illness, treatment, or abnormal test result that the trial doctor believes could make it unsafe for you to participate or could affect the study results
• You have had a cancer diagnosis within the past 5 years — with the exception of certain fully treated skin cancers (confirm with trial site)

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