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Last Updated: December 11, 2019

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CLINICAL TRIALS PROFILE FOR TAFAMIDIS

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All Clinical Trials for Tafamidis

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00925002 Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis Active, not recruiting Pfizer Phase 3 2009-08-01 This is a Phase 3, open-label study designed to obtain additional, long-term, open-label safety and efficacy data for Fx-1006A and to continue to provide patients with 20 mg oral Fx-1006A (soft gel capsule) who have completed either Protocol Fx-006 (a 1 year, open-label extension study to Protocol Fx-005 which is a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of Fx-1006A) or Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization as well as the safety and tolerability of Fx-1006A) until market availability of Fx-1006A in individual patients' country of residence. Patients who successfully complete Protocol Fx-006 or Fx1A-201 will report to the clinical unit on Day 0 (Baseline) to sign the informed consent form and determine their eligibility for Protocol Fx1A-303. In addition, on Day 0 (Baseline), patients will have their entrance criteria reviewed and medical history and demography for all patients will be obtained. The relevant end of study assessments from Protocols Fx1A-201 and Fx-006 will serve as Baseline assessments for Protocol Fx1A-303 if these examinations were performed within 30 days of Day 0 (Baseline). For any patient successfully completing Protocol Fx-006, the Karnofsky Performance Scale Index will be assessed and the cranial nerve and upper limb components of the NIS will be performed and combined with the NIS-LL data from the end of study visit from Protocol Fx-006. If there is more than 30 days between the final study visit of Fx-006 or Fx1A-201 and Day 0 (Baseline) of Fx1A-303, all Day 0 study procedures will be performed (i.e., no data from the final study visits from the previous studies will be utilized). Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months. Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit to the clinical unit and, if female, a urine pregnancy test will be performed. An abbreviated physical examination (including weight and vitals signs) will be conducted at every other 6 month visit. A telephone call will be made at 3-month intervals between clinic visits to assess safety and the use of concomitant medications. For the evaluation of efficacy, the NIS, Norfolk QOL-DN, and Karnofsky Performance Scale Index will be performed on an annual basis (i.e., every other 6-month visit). An end of study visit will occur upon patient withdrawal (for any reason), program discontinuation by the Sponsor, or upon market availability of Fx-1006A in individual patients' country of residence.
NCT00935012 Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy Active, not recruiting Pfizer Phase 3 2009-09-01 Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type Transthyretin (ttr) Amyloid Cardiomyopathy. Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on Day 0, patients will have their entrance criteria reviewed, and medical histories and demographic characteristics obtained. The physical examination (including weight and vital signs) and the relevant end of study clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than 30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical laboratory assessments must be performed on Day 0. Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months. Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated physical examinations (including weight and vital signs) will also be performed at each 6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone call will be made at 3-month intervals between clinic visits to assess safety and use of concomitant medications. For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ, 6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition, echocardiograms will be performed every 12 months on an annual basis. An end of study visit including all safety and efficacy assessments will occur upon patient completion of the study, premature withdrawal (for any reason), or in the event of program discontinuation by the Sponsor.
NCT01369836 Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects Completed Pfizer Phase 1 2011-07-01 The purpose of this study is the following: - To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose. - To compare Japanese and Western PK profiles. - Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
NCT01435655 The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin Completed Pfizer Phase 3 2011-11-01 Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tafamidis

Condition Name

Condition Name for Tafamidis
Intervention Trials
Healthy 6
Healthy Volunteers 4
Transthyretin (TTR) Amyloid Cardiomyopathy 2
TTR Cardiomyopathy 2
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Condition MeSH

Condition MeSH for Tafamidis
Intervention Trials
Amyloidosis 5
Cardiomyopathies 5
Amyloid Neuropathies, Familial 2
Polyneuropathies 1
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Clinical Trial Locations for Tafamidis

Trials by Country

Trials by Country for Tafamidis
Location Trials
United States 39
Belgium 10
Japan 4
Spain 3
Italy 2
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Trials by US State

Trials by US State for Tafamidis
Location Trials
Maryland 4
California 3
New York 3
Massachusetts 3
Illinois 3
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Clinical Trial Progress for Tafamidis

Clinical Trial Phase

Clinical Trial Phase for Tafamidis
Clinical Trial Phase Trials
Phase 3 5
Phase 1 12
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Tafamidis
Clinical Trial Phase Trials
Completed 10
Active, not recruiting 3
Not yet recruiting 2
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Clinical Trial Sponsors for Tafamidis

Sponsor Name

Sponsor Name for Tafamidis
Sponsor Trials
Pfizer 17
Boston University 1
Corino Therapeutics, Inc. 1
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Sponsor Type

Sponsor Type for Tafamidis
Sponsor Trials
Industry 18
Other 1
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