A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors



Status:Recruiting
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - Any
Updated:1/25/2019
Start Date:March 22, 2018
End Date:August 10, 2020
Contact:Trial Transparency email recommended (Toll free number for US & Canada)
Email:Contact-US@sanofi.com
Phone:800-633-1610

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ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX

The purpose of this study is to determine the frequency of bleeding episodes in patients
receiving fitusiran as prophylactic treatment of hemophilia compared with patients who are
assigned to continue with their regular medication. In addition, the study will assess
safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).


Inclusion Criteria:

- Males, ≥12 years of age

- Severe hemophilia A or B with inhibitors

- (Severity confirmed by a central laboratory where FVIII level is <1% or FIX level
is ≤2% at Screening; Inhibitors defined as inhibitor titer of ≥0.6 BU/mL or as
evidenced by medical records)

- A minimum of 6 bleeding episodes requiring bypassing agent 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

Exclusion Criteria:

- 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 HCV infection

- HIV positive with a CD4 count of <200 cells/μL

- History of arterial or venous thromboembolism

- Inadequate renal function

- History of multiple drug allergies or history of allergic reaction to an
oligonucleotide or N-Acetylgalactosamine (GalNAc)

- History of intolerance to SC injection(s)

- 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 judgement
We found this trial at
9
sites
530 South Main Street
Akron, Ohio 44311
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6330 Quadrangle Drive
Chapel Hill, North Carolina 27517
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Las Vegas, Nevada 89109
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Las Vegas, NV
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89 Commercial Road
Melbourne, 3004
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Melbourne,
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New Orleans, Louisiana
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New Orleans, LA
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Orange, California
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Orange, CA
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Phoenix, Arizona 85016
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San Diego, California
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San Diego, CA
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Tampa, Florida
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Tampa, FL
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