Early Phase 1 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 willing to sign a consent form agreeing to take part in the study
• You are male and aged 18 or older
• You have been diagnosed with severe Hemophilia A, with a clotting factor VIII (FVIII) level below 1% of normal
• You have been treated with a FVIII product (either lab-made or derived from blood plasma) for at least 150 treatment days in total
• Your blood test shows a low level of certain antibodies against the virus used in this gene therapy (confirm with trial site)
• You have had a bleeding episode or used a FVIII product within the 12 weeks before the screening visit
• You have no history of allergic reactions to FVIII products
• Your blood shows a very low level of antibodies that interfere with FVIII treatment (confirm with trial site)
• You are willing to only take other medications during the study if approved by the research team
• You are willing and able to follow all study procedures and requirements
• You are willing to use effective contraception for 52 weeks after receiving the treatment

Who may not be able to join:

• You have tested positive for Hepatitis B, Hepatitis C, HIV, or syphilis
• Your liver or kidney function blood tests are significantly outside the normal range, or your red blood cells or platelets are too low
• You have a history of developing antibodies that block how FVIII works (called FVIII inhibitors)
• You have another condition that also affects bleeding, apart from Hemophilia A
• You are planning to have major surgery within 52 weeks of joining the trial
• You have a reason you cannot take steroid medications (such as certain allergies, epilepsy, unhealed fractures, uncontrolled infections, or severe bone thinning) — confirm specifics with trial site
• You have a history of allergic reactions to human albumin (a protein found in blood)
• You have a serious or active disease affecting the heart, lungs, digestive system, hormones, kidneys, blood, nervous system, or mental health
• You have hepatitis, cirrhosis, liver cancer, or another significant liver disease
• You have a history of cancer
• Your health checks or test results during screening show something that makes you unsuitable for the trial, in the opinion of the research team
• You have previously received any gene therapy treatment
• You have taken part in another clinical trial and received study medication within the past four weeks (or within five half-lives of that drug)
• The research team has any other concern that makes joining the trial inappropriate for you

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