Understanding the characteristics and treatment 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

This study is looking to understand the experiences and treatments of people with ATTR amyloidosis to see how the disease affects their lives and how it is managed over time.

Quick facts

• Study type: Observational
• Enrollment: 52121 (estimated)
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 26 sites (Eden Prairie, Minnesota and 25 other locations)
• Trial ID: NCT06355934 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world evidence on the disease journeys of patients diagnosed with ATTR amyloidosis. It will analyze baseline characteristics, treatment patterns, and various clinical, economic, and humanistic outcomes, such as quality of life and daily living activities. The study will follow patients longitudinally to assess healthcare resource utilization and outcomes both pre- and post-diagnosis. By characterizing these factors, the study seeks to provide a comprehensive understanding of how ATTR amyloidosis presents and is managed.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of ATTR amyloidosis.

Not a fit: Patients with primary (AL) or secondary (AA) amyloidosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding of ATTR amyloidosis, leading to better patient management and treatment strategies.

How similar studies have performed: Other studies have shown success in characterizing patient journeys in similar conditions, indicating that this approach is promising.

Eligibility criteria

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

Where this trial is running

Eden Prairie, Minnesota and 25 other locations

• Research Site — Eden Prairie, Minnesota, United States (Completed)
• Research Site — Calgary, Alberta, Canada (Recruiting)
• 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 (Completed)
• Research Site — Berlin, Germany (Completed)
• Research Site — Tokyo, Japan (Completed)
• Research Site — Lisbon, Portugal (Recruiting)
• Research Site — Porto, Portugal (Not_yet_recruiting)
• Research Site — A Coruña, 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 — Södertälje, Sweden (Completed)
• Research Site — Umeå, Sweden (Completed)
• Research Site — London, United Kingdom (Completed)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions ATTR Amyloidosis; ATTR-CM, ATTRv-PN