APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Completed · Phase 3 · Has a placebo group

Conditions studied: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

In brief

The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.

Key facts

Study ID

NCT03997383

Run by

Alnylam Pharmaceuticals

People needed

360

Starts

2019-09-04

Expected to finish

2025-12-24

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hereditary ATTR amyloidosis with cardiomyopathy or wild-type ATTR amyloidosis with cardiomyopathy
• Medical history of heart failure with at least 1 prior hospitalization for heart failure, or current clinical evidence (signs and symptoms of heart failure)
• Clinically stable with no cardiovascular related hospitalizations within 6 weeks of study start
• Has never taken tafamidis before (tafamidis naïve) or currently on tafamidis for ≥6 months with evidence of disease progression while on tafamidis treatment
• Able to complete ≥150 m on the 6-minute walk test
• Screening N-terminal pro B-type natriuretic peptide (NT-proBNP), a blood marker of heart failure severity, >300 ng/L and <8500 ng/L; in participants with permanent or persistent atrial fibrillation, screening NT-proBNP> 600 ng/L and <8500 ng/L

You may not qualify if…

• Known primary amyloidosis (AL) or leptomeningeal amyloidosis.
• Received prior TTR lowering treatment
• New York Heart Association heart failure classification of III and at high risk
• New York Heart Association heart failure classification of IV
• Neuropathy requiring cane or stick to walk, or is wheelchair bound
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m\^2
• Abnormal liver function
• Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
• Has non-amyloid disease that significantly affects ability to walk (e.g., severe chronic obstructive pulmonary disease, severe arthritis, or peripheral vascular disease affecting ambulation)
• Prior or planned heart, liver, or other organ transplant
• Other cardiomyopathy not related to ATTR amyloidosis

Where it is running

• Clinical Trial Site — Chicago, Illinois, United States
• Clinical Trial Site — Skokie, Illinois, United States
• Clinical Trial Site — Iowa City, Iowa, United States
• Clinical Trial Site — Kansas City, Kansas, United States
• Clinical Trial Site — Baltimore, Maryland, United States
• Clinical Trial Site — Boston, Massachusetts, United States
• Clinical Trial Site — Burlington, Massachusetts, United States
• Clinical Trial Site — Rochester, Minnesota, United States
• Clinical Trial Site — St Louis, Missouri, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — Cleveland, Ohio, United States
• Clinical Trial Site — Philadelphia, Pennsylvania, United States
• Clinical Trial Site — Philadelphia, Pennsylvania, United States
• Clinical Trial Site — Pittsburgh, Pennsylvania, United States
• Clinical Trial Site — Nashville, Tennessee, United States
• Clinical Trial Site — Dallas, Texas, United States
• Clinical Trial Site — Norfolk, Virginia, United States
• Clinical Trial Site — Buenos Aires, Argentina
• Clinical Trial Site — Buenos Aires, Argentina
• Clinical Trial Site — Córdoba, Argentina
• Clinical Trial Site — Rosario, Argentina
• Clinical Trial Site — Rosario, Argentina
• Clinical Trial Site — Rosario, Argentina
• Clinical Trial Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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