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

NCT03997383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-04-20

Study results available
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Summary

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

Conditions

  • Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Interventions

DRUG

Placebo

Normal saline (0.9% NaCl) matching volume of patisiran doses will be administered intravenously.

DRUG

Patisiran

Patisiran will be administered by intravenous (IV) infusion.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2022-06-20
Completion
2025-12-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Czechia
  • Denmark
  • France
  • Hong Kong
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • South Korea
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997383 on ClinicalTrials.gov