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:

• You have been diagnosed with severe or moderate congenital hemophilia A (a condition where your blood does not clot properly due to low levels of a protein called Factor VIII).
• You may have developed antibodies (called "inhibitors") against Factor VIII treatments, or you may not have — both are accepted.
• If you do have inhibitors, you are already using a specific clotting treatment called rFVIIa, or you are willing to switch to it for treating bleeds, injuries, or procedures.
• Past test results about your inhibitor history are available for review during the screening process.
• If you previously completed a treatment program to reduce inhibitors (called immune tolerance induction), it must have been completed at least 5 years ago with no sign of inhibitors coming back since then (confirm with trial site).
• You have records of how many bleeds you had and what type they were in the 24 weeks before joining.
• Your blood cell counts (platelets and hemoglobin) are at healthy enough levels at the time of screening.
• Your liver is functioning well enough, based on blood test results, and you do not have signs of serious liver scarring (confirm with trial site).
• Your kidneys are functioning well enough, based on blood test results — the exact level required depends on which part of the trial you join (confirm with trial site).
• You are willing and able to attend all scheduled visits and follow all study requirements.

Who may not be able to join:

• You have a bleeding disorder other than congenital hemophilia A, whether inherited or developed over time.
• You are currently undergoing or planning to undergo immune tolerance induction (a treatment to reduce inhibitors).
• You have been treated for blood clots in the past or are currently showing signs of blood clotting problems (with a limited exception for clots related to catheters that are no longer being treated — confirm with trial site).
• You are considered at high risk for a condition affecting small blood vessels called thrombotic microangiopathy, including if you or a close family member has had this condition before.
• For one part of the trial only: You have a personal history of heart disease, stroke, or diabetes.
• For one part of the trial only: You have a strong family history of heart disease or stroke in close relatives (parents, siblings, or children) at a relatively young age (confirm with trial site).
• For one part of the trial only: You have had or currently have cancer or leukemia.
• You have another health condition, such as certain autoimmune diseases, that may increase your risk of bleeding or blood clots.
• You have a history of significant allergic reactions.
• You have recently received an experimental drug for hemophilia, a non-hemophilia experimental drug, or any other experimental treatment — or you have plans to receive one during the study.
• You have previously received gene therapy, or you plan to receive it.
• You are currently taking or plan to take medications that affect your immune system (such as interferon or rituximab), unless it is HIV treatment.
• Certain proteins in your blood that are related to clotting (Protein C, Protein S, or anti-thrombin III) are below normal levels at screening.
• You have HIV with a very low immune cell count (CD4 count below 200 cells/μL).
• You have had a severe allergic or anaphylactic reaction to a type of medication called a monoclonal antibody, or to similar biological treatments.
• You are known to be allergic to the ingredients used in producing this type of medication (confirm with trial site).
• You have a heart rhythm problem that a doctor considers clinically significant, including atrial fibrillation or signs of a previous heart attack.
• Your heart's electrical activity (measured by an ECG) shows a specific abnormality called a prolonged QT interval on at least two tests.
• You have a history of serious heart rhythm problems or risk factors for them, such as structural heart disease, coronary heart disease, significant electrolyte imbalances, or a family history of sudden unexplained death or a condition called long QT syndrome.
• You are currently taking medications that are well known to affect heart rhythm (specifically those that prolong the QT interval).

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