Transthyretin-Associated Amyloidosis Outcome Survey (THAOS)
NCT00628745
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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.
Participant presenting with any of the following will not be included in THAOS:
1. Participant has primary or secondary amyloidosis.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Transthyretin-Associated Amyloidosis Outcome Survey (THAOS) | ||||
| Official Title | Transthyretin Amyloidosis Outcomes Survey (THAOS): A Global, Multi-Center, Longitudinal, Observational Survey of Patients With Documented Transthyretin Gene Mutations or Wild-Type Transthyretin Amyloidosis. | ||||
| Brief Summary | THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidosis (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. | ||||
| Detailed Description | n/a NA | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: whole blood | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Participants with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. | ||||
| Condition |
| ||||
| Intervention | Other: None. Observational Study. | ||||
| Study Groups/Cohorts | Observational
Intervention: Other: None. Observational Study. | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 8000 | ||||
| Original Estimated Enrollment | 1000 | ||||
| Estimated Study Completion Date | June 18, 2023 | ||||
| Estimated Primary Completion Date | June 18, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into THAOS:
Exclusion Criteria Participant presenting with any of the following will not be included in THAOS: 1. Participant has primary or secondary amyloidosis. | ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Argentina, Belgium, Brazil, Bulgaria, Canada, Cyprus, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Portugal, Romania, Spain, Sweden, Taiwan, Turkey, United States | ||||
| Removed Location Countries | Australia, Austria, Greece, Switzerland | ||||
| Administrative Information | |||||
| NCT Number | NCT00628745 | ||||
| Other Study ID Numbers | B3461001 FX-R-001 ( Other Identifier: Alias Study Number ) THAOS ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | March 2021 | ||||