This trial is active, not recruiting.

Condition ttr-mediated amyloidosis
Treatment revusiran (aln-ttrsc)
Phase phase 2
Sponsor Alnylam Pharmaceuticals
Start date October 2014
End date October 2016
Trial size 25 participants
Trial identifier NCT02292186, ALN-TTRSC-003


Dosing discontinued; Follow-up of patients for safety

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
revusiran (aln-ttrsc)

Primary Outcomes

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

Secondary Outcomes

Assessment of changes from baseline in serum TTR
time frame: From Baseline to Day 1372
time frame: From Baseline to Day 1344
Frequency of cardiovascular-related and heart failure-related hospitalizations
time frame: From Baseline to Day 1344
6-minute walk test performance
time frame: From Baseline to Day 1344

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the ALN-TTRSC-002 study - Adequate liver function - Not Pregnant or nursing Exclusion Criteria: - Inadequate renal function - Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac arrhythmia - Untreated hypo- or hyperthyroidism - Prior major organ transplant

Additional Information

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 Amyloidosis Who Have Previously Received ALN-TTRSC
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Alnylam Pharmaceuticals.