Not currently recruiting at UCSF

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

a study on Cardiomyopathy

Summary

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

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

  • Teresa De Marco
    CLINICAL INTERESTS: Advanced heart failure, cardiomyopathies, heart transplantation, mechanical circulatory support, and pulmonary hypertension RESEARCH INTERESTS: Translational research in the diagnosis, prognosis, medical and surgical treatment for the above disease states

Details

Status
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
Study Type
Interventional
Last Updated