Phase 3 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:
- You are willing to voluntarily sign a consent form to take part in the study
- You are male and aged 18 or older
- You have been clinically diagnosed with severe hemophilia A
- You have had at least 150 documented treatment sessions using a Factor VIII (clotting factor) product
- You have never had a severe allergic reaction (such as anaphylaxis) to a Factor VIII or immunoglobulin product
- You are willing to use a reliable form of contraception throughout the study
- A blood test shows you do not have certain antibodies against the gene therapy delivery vehicle (capsid antibody negative) (confirm with trial site)
- You are able and willing to follow all study requirements consistently
Who may not be able to join:
- You currently test positive for hepatitis B or hepatitis C, HIV, or syphilis (those with a past history of hepatitis B or C may still be considered if two tests taken at least 3 months apart are both negative)
- You are currently taking antiviral medication for hepatitis B or C
- You have a blood clotting disorder other than hemophilia A
- You are currently using immunosuppressant medications other than steroids (glucocorticoids)
- You have received a vaccine in the past 2 months, or have vaccines planned during the treatment period
- You have a significant liver condition, such as portal hypertension, liver scarring (fibrosis stage 3 or higher), liver cysts or nodules, or abnormal liver-related blood test results
- You have a major planned surgery scheduled during the study period
- You have previously taken part in a gene therapy trial, used another experimental drug within 4 weeks before screening (or within 5 half-lives of that drug), or received emicizumab within 6 months before screening
- You have taken herbal supplements or traditional medicines in the 4 weeks before or during the study that could affect liver function (except products applied to the skin)
- You have an alcohol or drug dependency, or are unable to stop drinking alcohol as advised during the study
- You have active or ongoing infections, a history of cancer, serious mental health concerns (including risk of suicide), or any other unstable health conditions the study doctor considers unsuitable
- You have any other condition that the study doctor believes makes participation unsuitable
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: Lei Zhang, MD, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
Phone: 13636317441
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Phase 1/2: Incidence of dose limiting toxicity (DLT) events; Phase 1/2: The incidence of adverse events (AEs) and serious adverse events (SAEs); Phase 1/2: Number of participants with changes in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels [liver function]; Phase 3: Annualized bleeding rate (ABR)
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.