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NCT06355934Recruiting

OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

AstraZeneca

Start Date

8/21/2023

Completion Date

9/30/2026

Summary

The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented.

Detailed Description

This retrospective, observational, longitudinal, multi-country cohort study aims to describe characteristics, treatment patterns, and outcomes in ATTR amyloidosis patients. Primary objectives: Describe patient characteristics (for example demographics, family history of ATTR, key comorbidities and humanistic outcomes (e.g. Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments), treatment patterns, and disease outcomes. Characterize and quantify the healthcare resource utilization (HCRU) in ATTR amyloidosis patients who will be followed post-index until the end of follow-up. Secondary objectives: Describe demographics, clinical characteristics and HCRU in ATTR amyloidosis patients prior to diagnosis.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Patients aged \>18 years at study index date AND * A reported diagnosis code for amyloidosis OR * A claim for ATTR-specific treatment OR * A positive biopsy for amyloidosis and positive immunostaining result of biopsy for ATTR Exclusion Criteria: * Evidence of primary (AL) and secondary (AA) amyloidosis AND/OR * At least one claim/procedure code for stem cell transplant or at least two claims/procedure codes for chemotherapy and autoimmune disease drugs which may represent AL (primary) or AA (secondary) amyloidosis treatments

Interventions

OTHER

no intervention

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Conditions

ATTR Amyloidosis

Locations

Research Site

Eden Prairie, Minnesota 55344

United States

Research Site

Calgary, Alberta T2P 4K7

Canada

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Beijing,

China

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Changsha,

China

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Chengdu,

China

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Guangzhou,

China

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Wuhan,

China

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Horsens,

Denmark

Research Site

Berlin,

Germany

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Lecce,

Italy

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Messina,

Italy

Research Site

Milan,

Italy

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Tokyo,

Japan

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Lisbon,

Portugal

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Porto,

Portugal

Research Site

A Coruña,

Spain

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Barcelona,

Spain

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Bilbao,

Spain

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El Palmar,

Spain

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Huelva,

Spain

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Las Palmas de Gran Canaria,

Spain

Research Site

Madrid,

Spain

Research Site

Majadahonda,

Spain

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Palma de Mallorca,

Spain

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Salamanca,

Spain

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Valencia,

Spain

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Södertälje,

Sweden

Research Site

Umeå,

Sweden

Research Site

London,

United Kingdom