Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

  • STATUS
    Recruiting
  • End date
    Feb 16, 2027
  • participants needed
    2000
  • sponsor
    Pfizer
Updated on 13 June 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Kurume University Hospital (0.6 mi away) Contact
+144 other location

Summary

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

Description

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.

Details
Condition Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin (TTR) Amyloid Cardiomyopathy, Transthyretin Amyloid Cardiomyopathy
Treatment Tafamidis meglumine, tafamidis
Clinical Study IdentifierNCT02791230
SponsorPfizer
Last Modified on13 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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