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Recruiting NCT06355934

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

Conditions: ATTR Amyloidosis

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
no intervention
OTHER
Locations 26
Canada (1)
Research Site
Calgary , Alberta
China (5)
Research Site
Beijing
COMPLETED
Research Site
Changsha
COMPLETED
Research Site
Chengdu
COMPLETED
Research Site
Guangzhou
COMPLETED
Research Site
Wuhan
COMPLETED
Denmark (1)
Research Site
Horsens
COMPLETED
Germany (1)
Research Site
Berlin
COMPLETED
Japan (1)
Research Site
Tokyo
COMPLETED
Portugal (2)
Research Site
Lisbon
Research Site
Porto
NOT_YET_RECRUITING
Spain (11)
Research Site
A Coruña
COMPLETED
Research Site
Barcelona
COMPLETED
Research Site
Bilbao
COMPLETED
Research Site
El Palmar
COMPLETED
Research Site
Huelva
COMPLETED
Research Site
Las Palmas de Gran Canaria
COMPLETED
Research Site
Madrid
COMPLETED
Research Site
Majadahonda
COMPLETED
Research Site
Palma de Mallorca
COMPLETED
Research Site
Salamanca
COMPLETED
Research Site
Valencia
COMPLETED
Sweden (2)
Research Site
Södertälje
COMPLETED
Research Site
Umeå
COMPLETED
United Kingdom (1)
Research Site
London
COMPLETED
United States (1)
Research Site
Eden Prairie , Minnesota
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
21.08.2023
Completion date
30.09.2026
Registry ID
NCT06355934
Source
clinicaltrials.gov
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