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

Last updated: May 7, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Treatment

no intervention

Clinical Study ID

NCT06355934
D8450R00004
  • All Genders

Study 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 Criteria

Inclusion

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 forATTR

Exclusion

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 twoclaims/procedure codes for chemotherapy and autoimmune disease drugs which mayrepresent AL (primary) or AA (secondary) amyloidosis treatments

Study Design

Total Participants: 55000
Treatment Group(s): 1
Primary Treatment: no intervention
Phase:
Study Start date:
August 21, 2023
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Research Site

    Calgary, Alberta T2P 4K7
    Canada

    Site Not Available

  • Research Site

    Ontario,
    Canada

    Site Not Available

  • Research Site

    Beijing,
    China

    Completed

  • Research Site

    Changsha,
    China

    Completed

  • Research Site

    Chengdu,
    China

    Completed

  • Research Site

    Guangzhou,
    China

    Completed

  • Research Site

    Wuhan,
    China

    Completed

  • Research Site

    Horsens,
    Denmark

    Active - Recruiting

  • Research Site

    Horses,
    Denmark

    Site Not Available

  • Research Site

    Berlin,
    Germany

    Active - Recruiting

  • Research Site

    Tokyo,
    Japan

    Completed

  • Research Site

    Barcarena,
    Portugal

    Site Not Available

  • Research Site

    Lisbona,
    Portugal

    Site Not Available

  • Research Site

    Porto,
    Portugal

    Site Not Available

  • Research Site

    A Coruna,
    Spain

    Completed

  • Research Site

    Barcelona,
    Spain

    Completed

  • Research Site

    Bilbao,
    Spain

    Completed

  • Research Site

    El Palmar,
    Spain

    Completed

  • Research Site

    Huelva,
    Spain

    Completed

  • Research Site

    Las Palmas de Gran Canaria,
    Spain

    Completed

  • Research Site

    Madrid,
    Spain

    Completed

  • Research Site

    Majadahonda,
    Spain

    Completed

  • Research Site

    Palma de Mallorca,
    Spain

    Completed

  • Research Site

    Salamanca,
    Spain

    Completed

  • Research Site

    Valencia,
    Spain

    Completed

  • Research Site

    Sodertalje,
    Sweden

    Completed

  • Research Site

    Umea,
    Sweden

    Active - Recruiting

  • Research Site

    London,
    United Kingdom

    Completed

  • Research Site

    Eden Prairie, Minnesota 55344
    United States

    Completed

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