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 male, between 12 and 65 years old at the time of signing the consent form, weigh at least 30 kg (about 66 lbs), and have a body mass index (BMI) under 28.
- If you have inhibitors (antibodies that block clotting treatments): you have tested positive for high-level or low-level inhibitors against clotting factor VIII or IX at a recent screening test, and if your inhibitor level is low, you are currently being treated with bypassing agents (medicines that work around the inhibitor).
- If you do not have inhibitors: you have severe or moderately severe hemophilia A or hemophilia B, your clotting factor activity is 2% or below, your inhibitor test is negative, you have no history of inhibitors (or any past inhibitors have been undetectable for at least 5 years), and you have used clotting factor replacement therapy for at least 100 treatment days before joining the study.
- You agree to follow specific rules about which treatments can be used if you have a bleeding episode during the trial (confirm with trial site for details relevant to your situation).
Who may not be able to join:
- You have a serious or poorly controlled long-term illness or a significant disease affecting your whole body.
- You have a history of blood clots (such as deep vein thrombosis or pulmonary embolism), currently have symptoms of a blood clot, or are taking blood clot-dissolving or blood-thinning medicines.
- You have known risk factors for developing blood clots, such as an irregular heartbeat (atrial fibrillation), significant artery disease, reduced blood flow to important organs, blocked blood vessels, certain autoimmune conditions linked to clotting risk, or a permanent central line (catheter) in a large vein.
- You have a known or suspected allergy to any ingredient in the trial medicine or related products.
- You have had a major surgical procedure within the 3 months before screening, or you have a planned surgery scheduled during the study period.
- You have been treated with the medicine Emicizumab within the 6 months before screening.
- You have ever received gene therapy for hemophilia at any point in the past.
- The trial doctor has identified another reason they consider you unsuitable for the trial, such as another medical condition, treatment, or abnormal test result that could affect your safety or the reliability of the trial results (confirm with trial site).
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: Renchi Yang, Doctor, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Phone: +86 18914005458
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
Incidence of TEAE.; Incidence of TEAE related to the experimental drug.; Incidence of SAE.; Incidence of thromboembolic events.; Incidence of TMA and DIC.; Incidence of hypersensitivity type reactions.; Incidence of injection site reactions.; Incidence of clinically significant laboratory value abnormalities.; Number of participants with clinically significant changes from baseline in electrocardiograms.; Number of participants with clinically significant changes from baseline in vital signs.; Number of participants with clinically significant changes from baseline in physical exam.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.