A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
12–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of severe congenital hemophilia A or B (FVIII \<1% or FIX level ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence.
For participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months prior to screening.
Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of participants under the age of legal consent, per local and national requirements
You may not be if
Known co-existing bleeding disorders other than congenital hemophilia A or B
History of arterial or venous thromboembolism, not associated with an indwelling venous access
History of intolerance to SC injection(s).
Current participation in immune tolerance induction therapy (ITI)
Prior gene therapy
Current or prior participation in a fitusiran trial
Current or prior participation in a gene therapy trial
Received an investigational drug or device within 30 days prior to the screening visit or within 5 half-lives of the investigational drug (or device) prior to the screening visit, whichever is longer
Presence of clinically significant liver disease AT activity \<60% at Screening
Co-existing 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.
Clareo Health | A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
