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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-02-22

Brief Summary

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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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Detailed Description

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Conditions

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TTR-mediated Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revusiran (ALN-TTRSC)

Group Type EXPERIMENTAL

Revusiran (ALN-TTRSC)

Intervention Type DRUG

Interventions

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Revusiran (ALN-TTRSC)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No