Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
- Registration Number
- NCT02791230
- Lead Sponsor
- Pfizer
- Brief Summary
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1733
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
-Liver and/or heart transplant, or implanted cardiac mechanical assist device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tafamidis Tafamidis Active treatment - 61 mg or if not available, tafamidis meglumine 80 mg
- Primary Outcome Measures
Name Time Method Time to All-Cause Mortality: Cohort A From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months] Time to all-cause mortality was calculated from first dose of randomized treatment in parent study (B3461028) to all-cause mortality events. All-cause mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to Adverse event (AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. Therefore, this analysis was based on the pooled dose groups, as per the statistical analysis plan (SAP).
Number of Participants With All-Cause Mortality Events: Cohort B B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) All-cause mortality included all participants who had discontinue for transplantation (i.e. heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to AE), or alive at the time of analysis. Kaplan Meier method was used for analysis.
Number of Participants With Treatment-Emergent Adverse Events (AEs) B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) An AE was any untoward medical occurrence in a participant who received investigational product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and all Non-SAEs. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (80)
The Kirklin Clinic of UAB Hospital
🇺🇸Birmingham, Alabama, United States
Cardiovascular Clinical Trials Unit (CCTU)
🇺🇸Birmingham, Alabama, United States
University Hospital, University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
California Heart Center
🇺🇸Beverly Hills, California, United States
Cedars-Sinai Medical Care Foundation
🇺🇸Beverly Hills, California, United States
Altman Clinical Translational Research Institute
🇺🇸La Jolla, California, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California, San Diego Medical Center - Hillcrest
🇺🇸San Diego, California, United States
Center Adv Lab Medicine
🇺🇸San Diego, California, United States
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