Clinical Trial: Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-Label Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Exploratory Clinical Activity of ALN-TTRSC in Patients With Transthyretin (TTR) Cardiac
Brief Summary: The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. [ Time Frame: Up to 63 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC, CL, Vss, Vz) [ Time Frame: Up to 90 days ]
- Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels) [ Time Frame: Up to 90 days ]
Original Secondary Outcome:
- Pharmacokinetics (PK) of ALN-TTRSC (Cmax, tmax, t1/2, AUC, CL, Vss, Vz) [ Time Frame: Up to 90 days ]
- Effect of ALN-TTRSC on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels) [ Time Frame: Up to 90 days ]
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: November 6, 2013
Date Started: December 2013
Date Completion:
Last Updated: February 4, 2016
Last Verified: February 2016
