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 able to understand what the study involves, including its risks, and are willing to sign a consent form
- You are male and at least 18 years old
- You have been diagnosed with hemophilia A with very low or absent Factor VIII activity (1% or less), confirmed by a lab test or past medical records
- You have never had a serious allergic reaction (such as anaphylaxis) to a Factor VIII product
- You have no detectable Factor VIII inhibitors (antibodies that block Factor VIII), confirmed by at least two lab tests taken at least one week apart, or you have a documented history of no inhibitors after extensive Factor VIII treatment
- Your blood test results at screening meet specific healthy ranges for hemoglobin, platelets, liver function, and kidney function (confirm specific values with trial site)
- You agree to use reliable barrier contraception (such as condoms) until the end of the 52-week observation period and until three semen samples test negative for the study's gene therapy material
Who may not be able to join:
- You currently have active, clinically significant Hepatitis B or C (people who have naturally cleared the virus or successfully treated it may still be eligible — confirm with trial site)
- You are currently taking antiviral medications for Hepatitis B or C
- You have a history of long-term or ongoing infections or other chronic illnesses that could make participation unsafe
- You have taken part in a gene therapy trial in the past 52 weeks, or any other experimental drug study in the past 30 days
- You have a condition that means you cannot safely take steroid medications such as prednisone or prednisolone
- You have a history of blood clots, including deep vein thrombosis, stroke (non-bleeding type), pulmonary embolism, heart attack, or arterial blockage
- You have a known inherited or acquired condition that increases your risk of blood clots, including atrial fibrillation
- You are planning to have major surgery within the year following the study treatment
- You have a known allergy or sensitivity to the study's gene therapy carrier (vector)
- You have any other serious medical condition that, in the investigator's opinion, makes participation unsafe or unsuitable
- You are unable or unwilling to attend all required study visits and follow the study schedule
- You have a bleeding disorder that is not related to hemophilia A
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, Chinese Academy of Medical Science and Blood Disease Hospital
Phone: +82223909240
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 treatment- related adverse events; Percentage of subjects in each dose group with newly occurred clinically significant abnormalities in physical examination compared to the baseline.; Changes of Weighted Mean of vital signs (systolic blood pressure [SBP] and diastolic blood pressure [DBP], pulse rate, temperature, respiratory rate) from baseline at each assessment time point for each dose group; Changes of Mean Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST) from baseline at each assessment time point for each dose group; Immune respo...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.