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Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers

Last updated on November 9, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP), Transthyretin Cardiomyopathy (TTR-CM), Familial Amyloid Cardiomyopathy, Senile Systemic Amyloidosis (SSA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults (ages 18-85 years inclusive) diagnosed with TTR-FAP or TTR-CM and experiencing
symptoms or currently providing care for a patient with TTR-FAP or TTR-FAP

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Caregivers who formally care for a TTR-FAP or TTR-CM patient as part of their job
description and receive payment for their services.

NCT01604122
Pfizer
Completed
Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers

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Descriptive Information
Brief TitleBurden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers
Official TitleCross-sectional, Non-interventional Burden Of Disease (Bod) Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (Ttr-fap) Or Transthyretin Cardiomyopathy (ttr-cm) And Caregivers
Brief SummaryThis study is an online (web-based) or paper-based survey for patients with transthyretin familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to describe the emotional, physical, and financial impact of having TTR-FAP or caring for someone who has the disease.
Detailed DescriptionConvenience sample of patients and caregivers recruited through patient advocacy groups. Convenience sample.
Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAdults (ages 18-85 years inclusive) diagnosed with TTR-FAP or TTR-CM and experiencing symptoms or currently providing care for a patient with TTR-FAP or TTR-CM
Condition
  • Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP)
  • Transthyretin Cardiomyopathy (TTR-CM)
  • Familial Amyloid Cardiomyopathy
  • Senile Systemic Amyloidosis (SSA)
InterventionOther: No drug
No drug.
Study Groups/Cohorts
  • Patients
    Patients with TTR-FAP or TTR-CM. No drug will be administered; this is a non-interventional observational study.
    Intervention: Other: No drug
  • Caregivers
    Caregivers who are taking care of patients with TTR-FAP or TTR-CM. No drug will be administered; this is a non-interventional observational study.
    Intervention: Other: No drug
Publications *Stewart M, Shaffer S, Murphy B, Loftus J, Alvir J, Cicchetti M, Lenderking WR. Characterizing the High Disease Burden of Transthyretin Amyloidosis for Patients and Caregivers. Neurol Ther. 2018 Dec;7(2):349-364. doi: 10.1007/s40120-018-0106-z. Epub 2018 Aug 2.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: March 1, 2017)
1
Original Estimated Enrollment
 (submitted: May 22, 2012)
318
Actual Study Completion DateJuly 18, 2016
Actual Primary Completion DateJuly 27, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults (ages 18-85 years inclusive) diagnosed with TTR-FAP or TTR-CM and experiencing symptoms or currently providing care for a patient with TTR-FAP or TTR-FAP

Exclusion Criteria:

  • Caregivers who formally care for a TTR-FAP or TTR-CM patient as part of their job description and receive payment for their services.
Sex/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01604122
Other Study ID NumbersB3461036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2017

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

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1-800-718-1021

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