ConTTRibute: A Global Observational Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

NCT ID: NCT04561518

Last Updated: 2025-11-12

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

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-23

Study Completion Date

2030-09-01

Brief Summary

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The purpose of this study is to:

* Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
* Characterize the safety and effectiveness of patisiran and vutrisiran as part of routine clinical practice in the real-world clinical setting
* Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) variant

Detailed Description

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Conditions

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Transthyretin-Mediated Amyloidosis ATTR Amyloidosis

Keywords

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RNAi therapeutic Transthyretin TTR Amyloidosis Hereditary Transthyretin-mediated (hATTR) Amyloidosis hATTR amyloidosis Hereditary ATTR amyloidosis Wild-type amyloidosis wtATTR amyloidosis ATTRv amyloidosis ATTRwt amyloidosis Polyneuropathy Familial amyloid polyneuropathies ATTR Transthyretin amyloidosis TTR-mediated amyloidosis Polyneuropathies Amyloid neuropathies Amyloid neuropathies, familial Amyloidosis, familial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ATTR amyloidosis

Patients with a diagnosis of ATTR amyloidosis, hereditary or wild type, will be eligible for the study and will follow routine clinical care.

No interventions assigned to this group

Pre-symptomatic Carriers

Pre-symptomatic carriers with a known disease-causing TTR variant will be eligible for the study and will follow routine clinical care.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of ATTR amyloidosis or documented known disease-causing TTR variant for the cohort of pre-symptomatic carriers
* Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis

Exclusion Criteria

* Current enrollment in a clinical trial for any investigational agent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

La Jolla, California, United States

Site Status RECRUITING

Clinical Trial Site

Los Angeles, California, United States

Site Status COMPLETED

Clinical Trial Site

Jacksonville, Florida, United States

Site Status RECRUITING

Clinical Trial Site

Iowa City, Iowa, United States

Site Status RECRUITING

Clinical Trial Site

Kansas City, Kansas, United States

Site Status RECRUITING

Clinical Trial Site

Baltimore, Maryland, United States

Site Status RECRUITING

Clinical Trial Site

Boston, Massachusetts, United States

Site Status COMPLETED

Clinical Trial Site

New York, New York, United States

Site Status RECRUITING

Clinical Trial Site

Durham, North Carolina, United States

Site Status RECRUITING

Clinical Trial Site

Columbus, Ohio, United States

Site Status RECRUITING

Clinical Trial Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Clinical Trial Site

Austin, Texas, United States

Site Status RECRUITING

Clinical Trial Site

Houston, Texas, United States

Site Status RECRUITING

Clinical Trial Site

Salvador, , Brazil

Site Status RECRUITING

Clinical Trial Site

São Paulo, , Brazil

Site Status RECRUITING

Clinical Trial Site

Sofia, , Bulgaria

Site Status RECRUITING

Clinical Trial Site

Aarhus, , Denmark

Site Status RECRUITING

Clinical Trial Site

Copenhagen, , Denmark

Site Status RECRUITING

Clinical Trial Site

Bordeaux, , France

Site Status RECRUITING

Clinical Trial Site

Bron, , France

Site Status RECRUITING

Clinical Trial Site

Créteil, , France

Site Status RECRUITING

Clinical Trial Site

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Clinical Trial Site

Marseille, , France

Site Status RECRUITING

Clinical Trial Site

Berlin, , Germany

Site Status RECRUITING

Clinical Trial Site

Giessen, , Germany

Site Status RECRUITING

Clinical Trial Site

Hanover, , Germany

Site Status RECRUITING

Clinical Trial Site

Jerusalem, , Israel

Site Status RECRUITING

Clinical Trial Site

Ramat Gan, , Israel

Site Status RECRUITING

Clinical Trial Site

Milan, , Italy

Site Status RECRUITING

Clinical Trial Site

Naples, , Italy

Site Status RECRUITING

Clinical Trial Site

Palermo, , Italy

Site Status RECRUITING

Clinical Trial Site

Roma, , Italy

Site Status RECRUITING

Clinical Trial Site

Groningen, , Netherlands

Site Status RECRUITING

Clinical Trial Site

Lisbon, , Portugal

Site Status RECRUITING

Clinical Trial Site

Porto, , Portugal

Site Status RECRUITING

Clinical Trial Site

Barcelona, , Spain

Site Status RECRUITING

Clinical Trial Site

Madrid, , Spain

Site Status RECRUITING

Clinical Trial Site

Palma, , Spain

Site Status RECRUITING

Clinical Trial Site

New Taipei City, , Taiwan

Site Status RECRUITING

Clinical Trial Site

Taipei, , Taiwan

Site Status RECRUITING

Countries

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United States Brazil Bulgaria Denmark France Germany Israel Italy Netherlands Portugal Spain Taiwan

Central Contacts

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Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-ALNYLAM

Email: [email protected]

Alnylam Clinical Trial Information Line

Role: CONTACT

Phone: 1-877-256-9526

Email: [email protected]

Other Identifiers

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ALN-TTR02-013

Identifier Type: -

Identifier Source: org_study_id