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APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

NCT01960348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-04-22

Study results available
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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.

Conditions

  • TTR-mediated Amyloidosis
  • Amyloidosis, Hereditary
  • Amyloid Neuropathies, Familial
  • Familial Amyloid Polyneuropathies
  • Amyloid Neuropathies
  • Amyloidosis, Hereditary, Transthyretin-Related

Interventions

DRUG

patisiran (ALN-TTR02)

administered by intravenous (IV) infusion

DRUG

Sterile Normal Saline (0.9% NaCl)

administered by intravenous (IV) infusion

Sponsors & Collaborators

Principal Investigators

  • Jared Gollob · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Cyprus
  • France
  • Germany
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

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 NCT01960348 on ClinicalTrials.gov