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Closed (no longer recruiting)Last updated: 5 February 2024

APOLLO-B: This phase III trial is trying to understand how safe and effective a new drug (patisiran), compared to a placebo, is in people with Transthyretin Amyloidosis (ATTR) With CardiomyopathyAPOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Clinical summary

Summary

This is a randomised, quadruple blinded study with two arms. In the Experimental Arm, participants will be administered multiple doses of patisiran, administered via intravenous (IV) infusion. In the Placebo Comparator Arm, participants will be administered the placebo (normal saline) via IV.

Conditions

This trial is treating patients with Transthyretin Amyloidosis (ATTR) With Cardiomyopathy.

Cancer

Blood Cancers Haematological

Age

People18 - 85

Phase

III

Trial Acronym

APOLLO-B

More information

Trial Identifiers

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Trial sponsor

Alnylam Pharmaceuticals

Scientific Title

APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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