Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •Known co-existing bleeding disorders other than hemophilia A or B
• •Antithrombin (AT) activity \<60% at Screening
• •Co-existing thrombophilic disorder
• •Clinically significant liver disease
• •Active Hepatitis C virus infection
• •Acute or chronic Hepatitis B virus infection
• •Acute Hepatitis A or hepatitis E infection
• •HIV positive with a CD4 count of \<400 cells/μL
• •History of arterial or venous thromboembolism, unrelated to an indwelling venous access
• •Inadequate renal function
• •History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)
• •Subjects with central or peripheral indwelling catheters, with history of venous access complications leading to hospitalization and/or systemic anticoagulation therapy.
• •History of intolerance to subcutaneous (SC) injection(s)
• •Use of emicizumab (Hemlibra®) within 6 months prior to screening
• •Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgment
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.