Clinical Trial: APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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 Polyneurop
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: The difference between the ALN TTR02 and placebo groups in the change from baseline of modified Neuropathy Impairment Score+7 (mNIS+7) [ Time Frame: 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The difference between ALN-TTR02 and placebo in the change from baseline in quality of life [ Time Frame: 18 months ]
- The difference between ALN-TTR02 and placebo in the change from baseline in motor function [ Time Frame: 18 months ]
- The difference between ALN-TTR02 and placebo in the change from baseline in autonomic function [ Time Frame: 18 months ]
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: October 9, 2013
Date Started: November 2013
Date Completion: August 2017
Last Updated: October 17, 2016
Last Verified: October 2016
