Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Pfizer

Status and phase: Completed; Phase 3

Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy

Treatments: Drug: Tafamidis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02791230

2016-000868-42 (EudraCT Number)

B3461045

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,733 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,733 participants in 1 patient group

Tafamidis

Experimental group

Description:

Active treatment - 61 mg or if not available, tafamidis meglumine 80 mg

Treatment:

Drug: Tafamidis