Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:July 27, 2007
End Date:June 16, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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TRANSTHYRETIN-ASSOCIATED AMYLOIDOSIS OUTCOMES SURVEY (THAOS): A GLOBAL, MULTI-CENTER, LONGITUDINAL, OBSERVATIONAL SURVEY OF PATIENTS WITH DOCUMENTED TRANSTHYRETIN (TTR) MUTATIONS OR WILD-TYPE TTR AMYLOIDOSIS

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.

n/a NA

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be
eligible for enrollment into THAOS:

1. Evidence of a personally signed and dated informed consent document indicating that
the participant (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

2. Males and females 18 years of age.

3. Confirmed genotyped TTR mutation with or without a diagnosis of ATTR, or wild-type TTR
amyloidosis. Confirmation of wild-type TTR amyloidosis will be determined by genotyped
confirmation that patient does not possess a known mutation in TTR gene (ie, is a
carrier of wild-type allele only) via genetic testing and one of the following set of
criteria (A, B, or C):

1. Evidence of cardiac involvement by echocardiogram as defined by mean left
ventricle wall thickness of >12 mm, and presence of amyloid in cardiac biopsy
tissue confirmed as TTR amyloid by mass spectrometry or immunohistochemistry; or

2. 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 mass spectrometry or immunohistochemistry; or

3. Evidence of cardiac involvement by echocardiogram as defined by mean left
ventricle wall thickness of >12 mm, no evidence of primary (light chain)
amyloidosis, and presence of amyloid in cardiac tissue indirectly confirmed by
scintigraphy with a "bone seeking tracer" eg, 99mTC-DPD
[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid], 99mTC- PYP
[Pyrophosphate], and 99mTC-HMDP [hydroxymethylene diphosphonate] with Perugini
grade greater than or equal to 2.

Exclusion Criteria

Participant presenting with any of the following will not be included in THAOS:

1. Participant has primary or secondary amyloidosis.
We found this trial at
46
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1720 2nd Ave S
Birmingham, Alabama 35233
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3181 Southwest Sam Jackson Park Road
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291 Campus Dr
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500 S State St
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Aurora, Colorado 80045
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1800 Orleans St.
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410-955-5000
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Baltimore, Maryland 20742
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655 West Baltimore Street
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Chicago, Illinois 60611
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303 East Superior Street
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5841 S Maryland Ave
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2049 E 100th St
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Deerfield Beach, Florida 33442
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McMurray, Pennsylvania 15317
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Nashville, Tennessee 37232
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630 W 168th St
New York, New York
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Oak Lawn, Illinois 60453
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Orange, California 92868
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Philadelphia, Pennsylvania 19140
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Pittsburgh, Pennsylvania 15213
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, Pennsylvania 15213
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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