RecruitingNCT06355934

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

OverTTuRe: An Observational Multi-Country Study Collecting Real-World Secondary Data on the Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis


Sponsor

AstraZeneca

Enrollment

52,121 participants

Start Date

Aug 21, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria4

  • 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 Criteria2

  • 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

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Interventions

OTHERno intervention

not applicable, this is an observational retrospective data analysis study; no interventions in the study


Locations(26)

Research Site

Eden Prairie, Minnesota, United States

Research Site

Calgary, Alberta, Canada

Research Site

Beijing, China

Research Site

Changsha, China

Research Site

Chengdu, China

Research Site

Guangzhou, China

Research Site

Wuhan, China

Research Site

Horsens, Denmark

Research Site

Berlin, Germany

Research Site

Tokyo, Japan

Research Site

Lisbon, Portugal

Research Site

Porto, Portugal

Research Site

A Coruña, Spain

Research Site

Barcelona, Spain

Research Site

Bilbao, Spain

Research Site

El Palmar, Spain

Research Site

Huelva, Spain

Research Site

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

Research Site

Valencia, Spain

Research Site

Södertälje, Sweden

Research Site

Umeå, Sweden

Research Site

London, United Kingdom

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NCT06355934


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