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

Alnylam Pharmaceuticals25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

TTR-mediated Amyloidosis

Interventions

Revusiran (ALN-TTRSC)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (5)

Clinical Trial Site

Boston, Massachusetts, United States

Clinical Trial Site

New York, New York, United States

Clinical Trial Site

Cleveland, Ohio, United States

Clinical Trial Site

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.

The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study \[drug\] discontinuation.

Time frame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months

Serum TTR Levels

Pharmacodynamic (PD) effect of long-term dosing of ALN-TTRSC on serum levels of TTR

Time frame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months

Secondary Outcomes

Mortality

Total number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes. Deaths were adjudicated by an independent adjudication committee as cardiovascular (CV) or non-CV events.

Time frame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months

Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization

Hospitalization events were adjudicated by an independent committee as cardiovascular (CV) or non-CV events

Time frame: Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months

6-minute Walk Test Performance

Distance in meters walked in 6 minutes

Time frame: Baseline, Month 6, and Month 12

Data from ClinicalTrials.gov

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