Phase 4 Haemophilia Trial, Recruiting

Written by an AI model from the 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 signed (or a parent/guardian has signed) a consent form agreeing to take part in the study
• You are male
• You have been diagnosed with mild congenital hemophilia A, meaning your body produces between 5% and 30% of the normal amount of a clotting protein called Factor VIII
• You have never had, and do not currently have, antibodies (called "inhibitors") that fight against Factor VIII treatment
• You have had any number of previous exposures to Factor VIII treatment, including those who have never been treated before
• Your Body Mass Index (BMI) is below 30
• You are between 5 and 45 years old
• You have medical records documenting your bleeding episodes, treatments used, and outcomes for the 12 months before joining the study
• You are willing and able to attend scheduled appointments, follow the study plan, keep a bleeding diary, complete health questionnaires, and use activity tracking tools provided by the study
• You are willing to take part in a medication test using a nasal spray called Stimate (DDAVP/desmopressin), unless you have previously had a bad reaction to it or it has been shown not to work well for you (confirm with trial site)
• Your liver is working well enough, based on blood test results, and you do not have signs of serious liver scarring (cirrhosis)
• Your blood cell counts and blood clotting levels are within an acceptable range, based on blood tests
• Your kidneys are working well enough, based on blood test results

Who may not be able to join:

• You have any bleeding disorder other than mild hemophilia A, or you have an additional bleeding disorder on top of your hemophilia A
• You currently have, or have ever had, inhibitor antibodies that work against Factor VIII treatment
• You are female
• You have a history of heart disease, are considered at high risk of a cardiovascular event (such as a heart attack or stroke) within the next 10 years, or have a history of reduced blood flow to the heart
• You are considered by the study doctor to be at high risk of a serious condition affecting small blood vessels, called TMA, based on your own or your family's medical history
• You have a history of illicit drug or alcohol misuse, either by your own report or in the study doctor's judgement
• You are currently being treated for a blood clot condition, or have been treated for one in the past 12 months, or show signs of having a blood clot (with some exceptions — confirm with trial site)
• You have other health conditions, such as certain immune system diseases, that may increase your risk of bleeding or blood clots
• You have previously had a significant allergic reaction to a type of medication called a monoclonal antibody, or to any ingredient in the study drug Hemlibra (emicizumab)
• You have HIV with a CD4 immune cell count below 200 cells per microlitre (people with HIV and a CD4 count of 200 or above may still be eligible)
• You are currently using, or plan to use during the study, medications that affect the immune system (such as interferon), not including HIV antiretroviral therapy
• You have another disease, condition, or are taking another medication that the study doctor believes could interfere with the study or put you at additional risk
• You have previously taken Hemlibra (emicizumab) as part of another research study, or have recently taken any other experimental drug related to hemophilia or other conditions (specific time limits apply — confirm with trial site)
• The study doctor does not think you will be able to follow the study requirements

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