Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Purpose
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Condition
- Transthyretin (TTR) Amyloid Cardiomyopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tafamidis |
Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer
Study Contact
Detailed 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.