Not currently recruiting at UCSF

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

a study on Cardiomyopathy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Mandar Aras
Photo of Mandar Aras
Mandar Aras

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

  • UCSF Ambulatory Care Center in progress, not accepting new patients
    San Francisco California 94143 United States
  • University of California in progress, not accepting new patients
    San Francisco California 94143 United States
  • UCSF Cardiovascular Care and Prevention Center in progress, not accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Mandar Aras
    My clinical interests are in the evaluation and management of patients with advanced heart failure and pulmonary hypertension, including patients requiring heart transplantation and left ventricular assist devices. I have a particular interest in prevention and treatment of patients with heart disease related to chemotherapy.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT02791230
Phase
Phase 3
Study Type
Interventional
Last Updated