Last updated 43 days ago
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
79 patients around the world
Available in Spain, United States, Mexico
Sanofi
79Patients around the world
This study is for people with
Hemophilia
Hemophilia a
Hemophilia b
Requirements for the patient
From 12 Years
Male
Medical requirements
- 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
- Known co-existing bleeding disorders other than congenital hemophilia A or BHistory of arterial or venous thromboembolism, not associated with an indwelling venous accessHistory of intolerance to SC injection(s).Current participation in immune tolerance induction therapy (ITI)Prior gene therapyCurrent or prior participation in a fitusiran trialCurrent or prior participation in a gene therapy trialReceived 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 longerPresence of clinically significant liver disease AT activity <60% at ScreeningCo-existing thrombophilic disorderHepatitis C virus antibody positive, except participants who have negative Hepatitis C viral load and no evidence of cirrhosisPresence of acute hepatitis, ie, hepatitis A, hepatitis E.Presence of acute or chronic hepatitis B infectionKnown 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.
StudyATLAS-NEO
SponsorSanofi
Conditions
Hemophilia aHemophilia b
Requirements
From 12 YearsMale
Unique study IDclinicaltrials.gov
NCT05662319
