Phase 2 Haemophilia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old at the time of signing the consent form, of any sex
• People who have been clinically diagnosed with Hemophilia A or B with very low clotting factor activity levels (FVIII below 1% or FIX at or below 2%), with or without inhibitors — those without inhibitors must have previously received clotting factor treatment for more than 50 exposure days
• People who have been clinically diagnosed with a congenital (inherited) Factor VII deficiency, with Factor VII activity below 10%
• For Part A of the trial only: People who received on-demand (as-needed) treatment for a bleeding episode using specific clotting products within 1 month before the screening visit
• For Parts B and C of the trial only: People who have accessible bleeding and treatment records going back at least 3 months before joining — people with Hemophilia A or B must have had at least 3 treated new bleeding episodes in that period, and people with Factor VII deficiency must have had at least 2 treated new bleeding episodes in that period
• People who have no active bleeding at the time of their first dose
• People who are able and willing to follow the trial's requirements, complete the study as planned, and provide biological samples as required
• People who have been fully informed about the trial and voluntarily agree to participate by signing the consent form themselves (or through a legally accepted representative)

Who may not be able to join:

• People with a known allergy or sensitivity to the trial medication or any of its ingredients
• People who cannot tolerate injections under the skin, or who have skin conditions at the injection site that could affect how the medication is given or how safety is assessed
• People whose blood test results at screening show any of the following: haemoglobin (red blood cell count) below 60 g/L; platelet count below 100 × 10⁹/L; liver or kidney function results that are significantly outside the normal range (confirm with trial site for specific values)
• People who test positive for hepatitis B surface antigen, HIV antibodies, and/or syphilis-specific antibodies
• People who have been clinically diagnosed with active hepatitis C
• People who have any other bleeding disorder or condition that significantly affects blood clotting, beyond Hemophilia A, Hemophilia B, or congenital Factor VII deficiency (for example, platelet disorders or vitamin K deficiency)
• People who have a deficiency in Protein C or Protein S (proteins involved in controlling blood clotting)
• People who have a current or past history of blood clots (thrombosis), a family history of blood clots, or a history of conditions that increase the risk of clotting
• People who have experienced bleeding inside the skull (intracranial haemorrhage) related to their bleeding disorder within the 2 years before screening
• People with serious heart conditions, such as unstable chest pain, significant heart failure, certain irregular heart rhythms, or uncontrolled high blood pressure (confirm specific thresholds with trial site)
• People who have recently received certain clotting treatment products within specific timeframes before the first dose — including rFVIIa within 48 hours, FVIII-containing products within 72 hours, or FIX-containing products within 96 hours (longer washout periods apply for long-acting versions — confirm with trial site)
• People who have used, or need to use, blood thinners, anti-clotting medicines, or medications that affect platelet function (including anti-inflammatory drugs such as aspirin) within 1 week before the first dose or during the trial
• People who have received whole blood or plasma therapy within 2 weeks before the first dose
• People who have received emicizumab treatment within 6 months before the first dose
• People who have received or are planning to receive a vaccine within 4 weeks before the first dose or during the trial
• People who have had major surgery within 1 month before the first dose, or who are planning to have surgery during the study
• People who have been enrolled in another clinical trial within 1 month before the first dose
• People with a history of drug misuse or heavy alcohol use (confirm specific criteria with trial site)
• People with a psychiatric illness, significant mental health condition, or other reason that affects their ability to understand or participate
• People who plan to have children or donate sperm during the trial or within 6 months after the last dose, or who are unwilling to use effective physical contraception (such as condoms)
• People with other significant medical conditions or circumstances that the trial investigator considers unsuitable for participation
• People who the investigator believes are unlikely to follow the trial requirements or complete the full course of treatment and follow-up

Important: Always verify eligibility with the trial site directly before applying.