Clinical Trial: A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-label Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTRSC in Patients With Transthyretin (TTR) Cardiac Amyloido
Brief Summary: The purpose of this study was to evaluate the safety and clinical activity of long-term dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being followed-up for safety.
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: Safety and tolerability of long-term dosing with revusiran (ALN-TTRSC) as measured by number of adverse events in patients with transthyretin (TTR) cardiac amyloidosis [ Time Frame: Up to 35 days post last dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assessment of changes from baseline in serum TTR [ Time Frame: From Baseline to Day 1372 ]
- Mortality [ Time Frame: From Baseline to Day 1344 ]Total number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes
- Frequency of cardiovascular-related and heart failure-related hospitalizations [ Time Frame: From Baseline to Day 1344 ]The number of times that a subject is hospitalized for cardiovascular- or heart failure- related causes
- 6-minute walk test performance [ Time Frame: From Baseline to Day 1344 ]Change from Baseline to Day 1344 in the total distance walked
Original Secondary Outcome:
- Assessment of changes from baseline in serum TTR [ Time Frame: From Baseline to Day 700 ]
- Mortality [ Time Frame: From Baseline to Day 672 ]Total number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes
- Frequency of cardiovascular-related and heart failure-related hospitalizations [ Time Frame: From Baseline to Day 672 ]The number of times that a subject is hospitalized for cardiovascular- or heart failure- related causes
- 6-minute walk test performance [ Time Frame: From Baseline to Day 672 ]Change from Baseline to Day 672 in the total distance walked
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: November 10, 2014
Date Started: October 2014
Date Completion:
Last Updated: May 23, 2017
Last Verified: May 2017