The objective of the study is to assess the long-term safety of patisiran in patients with ATTR amyloidosis with cardiomyopathy as assessed by a review of adverse events (AEs).
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Drug: Patisiran
Patisiran administered by intravenous (IV) infusion
Other Name: ONPATTRO
Other Name: ALN-TTR02
Inclusion Criteria: - Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy; AND - Had an inadequate response to or could not tolerate standard of care, in the opinion of the investigator. - Is not eligible for on-label use of commercial patisiran in the opinion of the investigator.
Exclusion Criteria: - New York Heart Association (NYHA) Class IV - NYHA Class III AND ATTR amyloidosis disease Stage 3 (defined as both N-terminal prohormone B-type natriuretic peptide (NT-proBNP) >3000 ng/L and estimated glomerular filtration rate [eGFR]
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California San Diego
San Diego, California, 92093
University of Chicago
Chicago, Illinois, 60637
Indiana University Health Hospital
Indianapolis, Indiana, 46202
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Boston University
Boston, Massachusetts, 02118
Washington University
Saint Louis, Missouri, 63110
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Columbia University Irving Medical Center
New York, New York, 10032
Cleveland Clinic
Cleveland, Ohio, 44195
OhioHealth Research Institute
Columbus, Ohio, 43214
Oregon Health & Science University
Portland, Oregon, 97239
Penn Presbyerian Medical Center
Philadelphia, Pennsylvania, 19104
Vanderbilt University
Nashville, Tennessee, 37232
Austin Neuromuscular Center
Austin, Texas, 78759
Baylor Scott & White Research Institute
Dallas, Texas, 75204
Alnylam EAP Hotline
(617) 715-0200
eap@alnylam.com
Medical Director
Study Director
Alnylam Pharmaceuticals