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Home » Clinical Trials » Amyloidosis

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of None. Observational Study. to evaluate Transthyretin Mutations or Transthyretin Amyloidosis

Research Study Title

A Global, Multi-Center, Longitudinal, Observational Survey Of Patients With Documented Transthyretin (TTR) Mutations Or Wild-Type TTR Amyloidosis

Purpose

THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate.

The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Pfizer

Duration

120 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Written informed consent.

  • Patient has confirmed: genotyped TTR mutation with or without a diagnosis of TTR-associated amyloidosis (e.g., ATTR-PN, ATTR-CM), or Wild-type TTR-associated amyloidosis with cardiomyopathy (wild-type ATTR-CM).

  • Confirmation of wild-type ATTR-CM will be determined by one of the following set of criteria (A or B):

A. Presence of amyloid in cardiac biopsy tissue confirmed as TTR amyloid by immunohistochemistry and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing; or B. Evidence of cardiac involvement by echocardiogram as defined by mean left ventricle wall thickness of > 12 mm, and presence of amyloid in non-cardiac tissue confirmed as TTR amyloid by immunohistochemistry, and genotyped confirmation that patient does not possess a known mutation in TTR gene (i.e., is a carrier of wild-type allele only) via genetic testing.

Exclusion Criteria:

  • Patient has primary or secondary amyloidosis.

Site Locations (53)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85054 Pfizer Investigational Site
United States California Orange 92868 Pfizer Investigational Site
United States California San Francisco 94117 Pfizer Investigational Site
United States California San Francisco 94143 Pfizer Investigational Site
United States California Stanford 94305-5406 Pfizer Investigational Site
United States Colorado Aurora 80045 Pfizer Investigational Site
United States Illinois Chicago 60637 Pfizer Investigational Site
United States Illinois Chicago 60611 Pfizer Investigational Site
United States Illinois Oak Lawn 60453 Pfizer Investigational Site
United States Maryland Baltimore 21201 Pfizer Investigational Site
United States Maryland Baltimore 21205 Pfizer Investigational Site
United States Massachusetts Boston 02215 Pfizer Investigational Site
United States Michigan Ann Arbor 48109 Pfizer Investigational Site
United States Minnesota Rochester 55905 Pfizer Investigational Site
United States New York New York 10034 Pfizer Investigational Site
United States New York New York 10032 Pfizer Investigational Site
United States Ohio Cleveland 44195 Pfizer Investigational Site
United States Ohio Columbus 43210 Pfizer Investigational Site
United States Oregon Portland 97201 Pfizer Investigational Site
United States Pennsylvania Philadelphia 19104 Pfizer Investigational Site
United States Pennsylvania Philadelphia 19140 Pfizer Investigational Site
United States Pennsylvania Pittsburgh 15212 Pfizer Investigational Site
United States Tennessee Nashville 37232 Pfizer Investigational Site
Argentina Buenos Aires C1428AQK Pfizer Investigational Site
Belgium Leuven 3000 Pfizer Investigational Site
Brazil Rio de Janeiro Ilha do Fundao 21941-913 Pfizer Investigational Site
Brazil Monte Alegre, Ribeirão Preto 14048-900 Pfizer Investigational Site
Denmark Aarhus N 8200 Pfizer Investigational Site
France Créteil 94000 Pfizer Investigational Site
France Fort de France 97200 Pfizer Investigational Site
France Lille Cedex 59037 Pfizer Investigational Site
France Paris 75013 Pfizer Investigational Site
France Paris cedex 10 75475 Pfizer Investigational Site
Germany Heidelberg D-69120 Pfizer Investigational Site
Germany Muenster 48149 Pfizer Investigational Site
Italy Bologna 40138 Pfizer Investigational Site
Italy Messina 98125 Pfizer Investigational Site
Italy Pavia 27100 Pfizer Investigational Site
Japan JP Matsumoto Pfizer Investigational Site
Japan Kumamoto Pfizer Investigational Site
Mexico Tlalpan 14000 Pfizer Investigational Site
Portugal Lisboa 1649-035 Pfizer Investigational Site
Portugal Lisbon 1649-035 Pfizer Investigational Site
Portugal Porto 4099001 Pfizer Investigational Site
Spain Spain. Madrid 28007 Pfizer Investigational Site
Spain Barcelona Pfizer Investigational Site
Spain Barcelona 8036 Pfizer Investigational Site
Spain Donostia-San Sebastian 20012 Pfizer Investigational Site
Spain Majadahonda 28222 Pfizer Investigational Site
Spain Palma de Mallorca 07198 Pfizer Investigational Site
Sweden Piteå 941 50 Pfizer Investigational Site
Sweden Umeå Pfizer Investigational Site
Turkey Istanbul 34093 Pfizer Investigational Site

Contact

Pfizer CT.gov Call Center
1-800-718-1021

NCT ID: NCT00628745

Date Last Changed: July 21, 2014

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