Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
estimated completion

Description

Summary

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Official Title

A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

Details

Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first.

Keywords

Transthyretin (TTR) Amyloid Cardiomyopathy amyloidosis amyloid transthyretin TTR ATTR-CM Cardiomyopathies Tafamidis

Eligibility

You can join if…

Open to people ages 18 years and up

Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028

Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028

You CAN'T join if...

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

Locations

  • UCSD Sulpizio Cardiovascular Center
    La Jolla California 92037 United States
  • University of California, San Diego Medical Center - Hillcrest
    San Diego California 92103 United States
  • 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
  • Center Adv Lab Medicine
    San Diego California 92121 United States
  • Altman Clinical Translational Research Institute
    La Jolla California 92037 United States
  • California Heart Center
    Beverly Hills California 90211 United States
  • Cedars-Sinai Medical Care Foundation
    Beverly Hills California 90211 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT02791230
Phase
Phase 3
Study Type
Interventional
Last Updated