CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
patisiran (ALN-TTR02) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01960348
NCT01960348Phase 3Completed
CompareCT.gov

APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)

Alnylam Pharmaceuticals·interventional·Posted Oct 10, 2013·Updated Apr 22, 2024

In Brief

A Phase 3 clinical trial evaluating patisiran (ALN-TTR02) and Sterile Normal Saline (0.9% NaCl) for TTR-mediated Amyloidosis and 5 related conditions. Completed, enrolled 225 participants across 52 sites in 21 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies, Amyloid Neuropathies, Amyloidosis, Hereditary, Transthyretin-Related
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Cyprus, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.7 years ago

Interventions

patisiran (ALN-TTR02)drug

administered by intravenous (IV) infusion

Sterile Normal Saline (0.9% NaCl)drug

administered by intravenous (IV) infusion