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

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NCT01604122

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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
0 +
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.

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Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP), Transthyretin Cardiomyopathy (TTR-CM), Familial Amyloid Cardiomyopathy, Senile Systemic Amyloidosis (SSA)Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers
NCT01604122
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers
Official Title Cross-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 Summary This 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 Description Convenience sample of patients and caregivers recruited through patient advocacy groups. Convenience sample.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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-CM
Condition
  • Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP)
  • Transthyretin Cardiomyopathy (TTR-CM)
  • Familial Amyloid Cardiomyopathy
  • Senile Systemic Amyloidosis (SSA)
Intervention Other: 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 Status Completed
Actual Enrollment
 (submitted: March 1, 2017)		1
Original Estimated Enrollment
 (submitted: May 22, 2012)		318
Actual Study Completion Date July 18, 2016
Actual Primary Completion Date July 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/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01604122
Other Study ID Numbers B3461036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017