The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

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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-TTR02 (patisiran)

Group Type EXPERIMENTAL

ALN-TTR02 (patisiran) administered by intravenous (IV) infusion

Intervention Type DRUG

Interventions

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ALN-TTR02 (patisiran) administered by intravenous (IV) infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Previously received and tolerated ALN-TTR02 (patisiran) in Study ALN-TTR02-002.
* Adequate Karnofsky performance status, liver function, and renal function.

Exclusion Criteria

* Pregnant or nursing.
* Has had a liver transplant.
* Has a New York Heart Association heart failure classification \>2.
* Has unstable angina.
* Has uncontrolled clinically significant cardiac arrhythmia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No