Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355934
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-02-12
Brief Title:
OverTTuRe Characteristics Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OverTTuRe
Brief 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 eg 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
Primary objectives Describe patient characteristics for example demographics family history of ATTR key comorbidities and humanistic outcomes eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None