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

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NCT01435655

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Kumamoto University Hospital/Department of Neurology
Kumamoto-shi, Kumamoto, 860-8556 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01435655
Pfizer
Completed
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin

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The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
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
Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Transthyretin Familial Amyloid Polyneuropathy
Drug: tafamidis
tafamidis meglumine 20 mg QD
Other Name: tafamidis meglumine
Experimental: open
tafamidis
Intervention: Drug: tafamidis
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01435655
B3461010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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