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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

Status
Recruiting
Phase
Study type
Observational
Enrollment
52,121 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERno interventionnot applicable, this is an observational retrospective data analysis study; no interventions in the study

Timeline

Start date
2023-08-21
Primary completion
2026-09-30
Completion
2026-09-30
First posted
2024-04-10
Last updated
2026-03-30

Locations

26 sites across 10 countries: United States, Canada, China, Denmark, Germany, Japan, Portugal, Spain, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT06355934. Inclusion in this directory is not an endorsement.