Clareo Health | A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
Male participants must be ≥12 years of age inclusive, at the time of signing the informed consent
Diagnosis of severe congenital hemophilia A (FVIII \< 1%) as evidenced by a central laboratory measurement at screening or documented medical record evidence.
* Inhibitor titer of ≥0.6 BU/mL at Screening, or
* Inhibitor titer of \<0.6 BU/mL at Screening with medical record evidence of 2 consecutive titers ≥0.6 BU/mL, or
* Inhibitor titer of \<0.6 BU/mL at Screening with medical record evidence of anamnestic response.
Participants who are currently on the full labeled dose of emicizumab prophylaxis, irrespective of inhibitor/non-inhibitor status.
Signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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Participants are excluded from the study if any of the following criteria apply:
Known coexisting bleeding disorders
History of antiphospholipid antibody syndrome.
History of arterial or venous thromboembolism, atrial fibrillation, significant valvular disease, myocardial infarction, angina, transient ischemic attack, or stroke. Participants who have experienced thrombosis associated with indwelling venous access may be enrolled.
Presence of clinically significant liver disease
Current or prior participation in a fitusiran trial
Current or prior participation in a gene therapy trial
AT activity \<60% at Screening, as determined by central laboratory measurement
Coexisting thrombophilic disorder - Hepatitis C virus antibody positive, except participants who have negative Hepatitis C viral load and no evidence of cirrhosis
Presence of acute hepatitis, ie, hepatitis A, hepatitis E.
Presence of acute or chronic hepatitis B infection
Known to be HIV positive with CD4 count \<200 cells/μL.
Reduced renal function
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
