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Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)

Last updated on April 2, 2019

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Study Location
UHealth Deerfield Beach
Deerfield Beach, Florida, 33442 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Mutations, Transthyretin Amyloidosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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Participant presenting with any of the following will not be included in THAOS:

1. Participant has primary or secondary amyloidosis.

NCT00628745
Pfizer
Recruiting
Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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