Phase 1 Haemophilia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are able to give informed consent and follow the study requirements
- Males aged 2 years or older who have a confirmed diagnosis of hemophilia B, with factor IX levels at or below 2% of normal
- People who have had an average of at least 4 bleeding episodes per year that required treatment with factor IX infusions, either on-demand or as a regular preventative treatment
- People who have no detectable factor IX inhibitors (antibodies that block factor IX) based on central laboratory testing, and no previous history of such inhibitors
- People who agree to use reliable barrier contraception until 3 consecutive tests show no trace of the study vector in their system
Who may not be able to join:
- People with significant liver problems, including abnormal levels of certain liver markers (alanine transaminase, bilirubin, or alkaline phosphatase)
- People with a history of inhibitors (antibodies) against factor IX
- People with active hepatitis B or C who are currently receiving antiviral treatment
- People with HIV-1 or HIV-2 whose immune cell (CD4) count is at or below 200/mm³ — note that people who are HIV-positive but stable, with a CD4 count above 200/mm³ and an undetectable viral load, may still be considered eligible (confirm with trial site)
- People with any active infection or any condition that weakens the immune system
- People who have taken part in a gene therapy trial within the past 6 months, or in any clinical trial involving an experimental drug within the past 12 weeks
- People who are unable or unwilling to follow the study assessments and requirements
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Lung-Ji Chang, PhD, Shenzhen Geno-Immune Medical Institute
Phone: +86 0755-86573763
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Number of participants experiencing drug-related adverse events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.