This study is in progress, not accepting new patients

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

a study on Transthyretin (TTR) Amyloid Cardiomyopathy

Summary

for people ages 18-90 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Teresa De Marco

Description

Summary

Phase 3 extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Extension Study To Evaluate The Safety Of Daily Oral Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg Or 80 Mg In Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)

Details

Global, Phase 3, double-blind, randomized, long-term extension study to evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with transthyretin cardiomyopathy (TTR-CM), who have completed 30 months of study treatment on Pfizer protocol B3461028, for up to 60 months or until local access to tafamidis for TTR-CM via prescription, whichever occurs first

Keywords

Transthyretin (TTR) Amyloid Cardiomyopathy amyloidosis amyloid transthyretin TTR Cardiomyopathies Tafamidis meglumine Tafamidis meglumine - 20 mg Tafamidis meglumine - 40 mg Tafamidis meglumine - 80 mg

Eligibility

You can join if…

Open to people ages 18-90

-Completion of 30 months of study treatment on Pfizer Protocol B3461028

You CAN'T join if...

-Liver and/or heart transplant, or implanted cardiac mechanical assist device

Locations

  • UCSF Ambulatory Care Center
    San Francisco California 94143 United States
  • University of California
    San Francisco California 94143 United States
  • UCSF Cardiovascular Care and Prevention Center
    San Francisco California 94158 United States
  • Stanford Hospital and Clinics Investigational Pharmacy
    Stanford California 94305 United States
  • Stanford University Hospital and Clinics
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02791230
Phase
Phase 3
Lead Scientist
Teresa De Marco
Study Type
Interventional
Last Updated
July 2, 2018