The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin
NCT01435655
Last updated date
ABOUT THIS STUDY
Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
Study Location
Kumamoto University Hospital/Department of Neurology
Kumamoto-shi, Kumamoto, 860-8556, Japan
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Kumamoto-shi, Kumamoto
- 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||