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Completed

NCT Number: NCT02292186

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

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.

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Key information

Conditions

TTR-mediated Amyloidosis Alzheimer Disease Brain Diseases Cardiomyopathies Cardiovascular Diseases Central Nervous System Diseases Dementia Heart Diseases Heart Failure Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revusiran (ALN-TTRSC)

Drug

Primary outcomes

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

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

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

  2. Serum TTR Levels

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

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

Secondary outcomes

  1. Mortality

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

    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.

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

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

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

  3. 6-minute Walk Test Performance

    Time frame: Baseline, Month 6, and Month 12

    Distance in meters walked in 6 minutes

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2014
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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