Transthyretin-Associated Amyloidoses Outcome Survey (THAOS) (THAOS)
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ClinicalTrials.gov Identifier: NCT00628745 |
Recruitment Status
:
Recruiting
First Posted
: March 5, 2008
Last Update Posted
: January 23, 2018
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Tracking Information | |||||
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First Submitted Date | February 25, 2008 | ||||
First Posted Date | March 5, 2008 | ||||
Last Update Posted Date | January 23, 2018 | ||||
Actual Study Start Date | July 27, 2007 | ||||
Estimated Primary Completion Date | June 16, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
The objectives of THAOS are to describe the population of patients affected with TTR amyloidoses and to enhance the understanding of the disease natural history, including the variability and progression of the hereditary and acquired forms of disease. [ Time Frame: Dec 2007 to June 2021 ] | ||||
Original Primary Outcome Measures | Not Provided | ||||
Change History | Complete list of historical versions of study NCT00628745 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Transthyretin-Associated Amyloidoses Outcome Survey (THAOS) | ||||
Official Title | 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 | ||||
Brief Summary | 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. |
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Detailed Description | n/a NA | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: whole blood |
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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 |
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Intervention | Other: None. Observational Study. | ||||
Study Groups/Cohorts | Observational
Intervention: Other: None. Observational Study. |
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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. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
1 | ||||
Original Estimated Enrollment |
1000 | ||||
Estimated Study Completion Date | June 16, 2021 | ||||
Estimated Primary Completion Date | June 16, 2021 (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 Patients presenting with any of the following will not be included in THAOS: 1. Patient has primary or secondary amyloidosis. |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
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, Mexico, Netherlands, Portugal, 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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | January 2018 |