Phase 2 N=25 Treatment

A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

TTR-mediated Amyloidosis

Bottom Line

View on ClinicalTrials.gov: NCT02292186 ↗

Enrolled (actual)

Serious AEs

88.0%

Results posted

Jun 2018

Primary outcome: Primary: Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients. — 25; 22; 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Revusiran (ALN-TTRSC) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alnylam Pharmaceuticals
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.	25; 22; 18	—
PRIMARY Serum TTR Levels	—	—
SECONDARY Mortality	8; 6	—
SECONDARY Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization	17; 15	—
SECONDARY 6-minute Walk Test Performance	-20.6; -104.6	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02292186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.