The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin

NCT01435655

Last updated date
Study Location
Kumamoto University Hospital/Department of Neurology
Kumamoto-shi, Kumamoto, 860-8556, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Familial Amyloid Polyneuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Transthyretin amyloid polyneuropathy with V30M or non-V30M transthyretin mutation.

- Subject had amyloid documented by biopsy in accordance with institutional site standard of care.

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


- Primary amyloidosis and secondary amyloidosis.


- History of liver transplant.

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Transthyretin Familial Amyloid PolyneuropathyThe Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin NCT01435655
  1. Kumamoto-shi, Kumamoto
  2. Matsumoto-shi, Nagano
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
Official Title  ICMJE The Effect On Transthyretin Stabilization, Safety, Tolerablity, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30m Or Non-v30m Transthyretin: A Phase Iii, Open-label Study
Brief Summary Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transthyretin Familial Amyloid Polyneuropathy
Intervention  ICMJE Drug: tafamidis
tafamidis meglumine 20 mg QD
Other Name: tafamidis meglumine
Study Arms  ICMJE Experimental: open
tafamidis
Intervention: Drug: tafamidis
Publications * Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Transthyretin amyloid polyneuropathy with V30M or non-V30M transthyretin mutation.
  • Subject had amyloid documented by biopsy in accordance with institutional site standard of care.

Exclusion Criteria:

  • Primary amyloidosis and secondary amyloidosis.
  • History of liver transplant.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01435655
Other Study ID Numbers  ICMJE B3461010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP