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 are male and 18 years of age or older
• You have a confirmed diagnosis of hemophilia B with very low levels of the clotting factor FIX (2% or less)
• You have been treated with FIX protein products (either lab-made or from plasma) on at least 100 separate occasions in the past
• In the past year, you have had at least 3 or more bleeding episodes and/or ongoing joint damage from hemophilia that needed treatment with FIX
• You agree to use reliable barrier contraception and not donate sperm for at least 52 weeks after receiving the study drug
• You are willing to take part fully, follow the study rules, complete all planned visits, and provide biological samples for testing

Who may not be able to join:

• You have had an allergic reaction to any ingredient in the study drug, including immunosuppressants (medicines that reduce immune system activity)
• You are unable to tolerate immunosuppressants or steroid medicines
• You have developed antibodies (inhibitors) against FIX, either currently or in the past
• You have a history of cancer, or currently have cancer of any kind
• You have an active autoimmune disease (a condition where your immune system attacks your own body)
• You have serious heart problems, such as angina, heart attack, heart failure, significant heart valve disease, or irregular heartbeat
• You have liver disease or a history of liver disease, such as scarring of the liver, fluid build-up in the abdomen, or other related conditions
• You currently have active hepatitis B or hepatitis C infection, or are receiving antiviral treatment for either condition
• You have diabetes that is not well controlled despite medication
• You have blood pressure that is too high or too low and not under control
• Your blood test results fall outside acceptable ranges — including low red blood cell levels, low platelets, abnormal liver function, abnormal kidney function, or low protein levels (confirm with trial site)
• You have tested positive for HIV or syphilis
• You have high levels of antibodies against a specific virus called AAV5 (used to deliver the gene therapy) (confirm with trial site)
• You have previously taken part in a gene therapy trial, used a FIX trial drug in the last month, or participated in any other drug or device trial in the last 3 months
• You have any planned surgery within 52 weeks after receiving the study drug
• You lost more than 400 mL of blood in the 3 months before joining the study
• You have epilepsy, a history of mental illness (such as schizophrenia, depression, or anxiety), or a condition that affects your ability to make decisions
• You have a history of drug abuse or alcohol dependency
• The trial team has concerns that you may not be able to follow the study requirements or complete all follow-up visits
• You have any other significant health condition or reason that the trial team considers unsuitable for participation

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