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:
- You (or your guardian) must be able to understand the study's purpose and risks, and sign a consent form
- You must be male, between 12 and 17 years old, and weigh at least 50 kg (about 110 lbs)
- You must have a confirmed diagnosis of hemophilia B with very low levels of the clotting factor FIX (2% or below), shown by laboratory tests
- You must have previously received at least 75 treatment sessions using FIX protein products (either from donated blood or lab-made)
- Your blood must show only low levels of certain antibodies that could interfere with the gene therapy being studied (confirm with trial site)
- You must have had a bleeding episode or needed a FIX treatment within the 12 weeks before screening
- You must have never had a serious allergic reaction to FIX products or IV immunoglobulin
- You must have no detectable antibodies that block FIX from working (called inhibitors), and no signs that FIX treatments have stopped working for you
- Your blood test results must fall within acceptable ranges for red blood cells, platelets, liver function, and kidney function
- If you are sexually active, you must agree to use reliable barrier contraception (such as condoms) for up to 52 weeks
- You must be willing and able to attend scheduled visits and keep a study diary
Who may not be able to join:
- You have active hepatitis B or hepatitis C, shown by blood tests
- You are currently taking antiviral medicines for hepatitis B or C
- You have a blood clotting disorder other than hemophilia B
- You have taken certain immune-suppressing medications (other than steroids or approved alternatives) within the past 30 days
- You have received a vaccine in the past 30 days, or have a vaccination planned during the 52-week study period
- You have a significant liver condition such as portal hypertension, an enlarged spleen, or liver-related brain problems, or any other liver condition the doctor feels makes gene therapy unsafe
- You have surgery planned within 52 weeks after receiving the gene therapy
- You have a history of serious ongoing infection, or a high risk of infection that the study doctor considers too risky
- You have taken part in a gene therapy study in the past 52 weeks, or any other clinical drug trial in the past 12 weeks
- You have taken herbal products that may affect liver function within the past 4 weeks
- You have a history of a life-threatening bleeding episode, such as bleeding in the brain
- You have any other serious illness or condition that the study doctor believes makes participation unsafe
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, Insitute of haematology and blood diseases hospital, chinese academy of medical sciences
Phone: +862223909240
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
The incidence of treatment related adverse events deemed related to BBM-H901 within 10 weeks after vector administration; The incidence of adverse events and serious adverse events within 52 weeks after BBM-H901 administration; Change from baseline aspartate amino transferase; Change from baseline alanine aminotransferase
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.