NCT03997383

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-09-12
• Primary completion: 2022-06-20
• Completion: 2027-03-15
• First posted: 2019-06-25
• Last updated: 2026-01-12
• Results posted: 2023-10-18

Locations

90 sites across 22 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

Regulatory

• FDA-regulated drug study