Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of ALN-TTRSC (revusiran) in Patients with Transthyretin (TTR) Cardiac Amyloidosis.

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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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ALN-TTRSC (revusiran)

Group Type EXPERIMENTAL

ALN-TTRSC (revusiran) for subcutaneous administration

Intervention Type DRUG

Interventions

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ALN-TTRSC (revusiran) for subcutaneous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* TTR cardiac amyloidosis;
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test, cannot be breast feeding, and must be willing to use 2 highly effective methods of contraception;
* Male subjects agree to use appropriate contraception;
* Adequate blood counts, liver, renal and heart function;
* Adequate Karnofsky performance status;
* Adequate New York Heart Association (NYHA) Classification Score;
* Clinically stable on heart medications;
* Adequate 6-minute walk test;
* Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria

* Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
* Subjects with a history of multiple drug allergies or intolerance to SC injection;
* Received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study;
* Uncontrolled hypertension, ischemic heart disease or cardiac arrhythmia;
* Untreated hypo- or hyperthyroidism;
* Prior major organ transplant;
* Considered unfit for the study by the Principal Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No