Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Transthyretin (TTR) Amyloid Cardiomyopathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791230
• Other study ID #: B3461045
• Secondary ID: 2016-000868-42
• Status: Completed
• Phase: Phase 3
• Start date: June 13, 2016
• Est. completion date: November 23, 2023

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1733
• Est. completion date: November 23, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Transthyretin (TTR) Amyloid Cardiomyopathy

Intervention

Drug:
• Tafamidis
Soft gel capsules administered once a day for 60 months

Locations

Country	Name	City	State
Argentina	Instituto Cardiovascular de Buenos Aires	Ciudad Autónoma de Buenos Aires
Australia	Eastern Health (Box Hill Hospital)	Box Hill	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	UZ Leuven	Leuven
Brazil	Hospital Universitário Clementino Fraga Filho (UFRJ)	Rio de Janeiro	RJ
Canada	University of Calgary/Foothills Medical Centre	Calgary	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Montreal Heart Institute-Research Center	Montreal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	University health network-Toronto General Hospital	Toronto	Ontario
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Institut klinicke a experimentalni mediciny	Praha 4
France	CHU Henri Mondor	Creteil
France	Hopital de La Timone	Marseille	CAN
France	Hôpital De La Timone	Marseille
France	Hopital Bichat	Paris
France	CHU de Rennes - Hopital Pontchaillou	Rennes
France	CHU de Rennes - Hôpital Pontchaillou	Rennes
France	CHU de Toulouse - Hôpital Rangueil	Toulouse
Germany	Medical University of Heidelberg	Heidelberg
Germany	Medizinisches Universitatsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Münster	Münster
Hong Kong	Clinical Trial Pharmacy	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Italy	Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Japan	Kumamoto University Hospital	Kumamoto-city	Kumamoto
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Shinshu University Hospital	Nagano
Netherlands	University Medical Center Groningen	Groningen
Spain	Unidad de Insuficiencia Cardiaca Avanzada y Transplante Cardiaco	A Coruna	LA Coruna
Spain	Complejo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Sweden	Skellefteå Lasarett	Skellefteå
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	Clinical Trial Pharmacy	Taipei
Taiwan	Investigational Drug Services	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Barts Health NHS Trust, St Bartholomew's Hospital	London
United States	Michigan Medicine - Department of Pharmacy Services - Research Pharmacy	Ann Arbor	Michigan
United States	Michigan Medicine,University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	California Heart Center	Beverly Hills	California
United States	Cedars-Sinai Medical Care Foundation	Beverly Hills	California
United States	Cardiovascular Clinical Trials Unit (CCTU)	Birmingham	Alabama
United States	The Kirklin Clinic of UAB Hospital	Birmingham	Alabama
United States	University Hospital, University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Boston Medical Center Investigational Pharmacy	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Northwestern Medical Group	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Sylvester at Deerfield Beach	Deerfield Beach	Florida
United States	Duke University	Durham	North Carolina
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 Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Vanderbilt Univ. Med. Ctr	Nashville	Tennessee
United States	Center for Advanced Cardiac Care	New York	New York
United States	Columbia University Irving Medical Center	New York	New York
United States	Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly	New York	New York
United States	NYU Langone Health	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	OHSU Center for Health and Healing	Portland	Oregon
United States	OHSU Research Pharmacy Services	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Hospital-Rochester	Rochester	Minnesota
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	University of Utah Hospitals & Clinics	Salt Lake City	Utah
United States	University of Utah, Division of Cardiovascular Medicine	Salt Lake City	Utah
United States	Center Adv Lab Medicine	San Diego	California
United States	University of California, San Diego Medical Center - Hillcrest	San Diego	California
United States	University of California, San Diego Medical Center - Hillcrest	San Diego	California
United States	UCSF Ambulatory Care Center	San Francisco	California
United States	UCSF Cardiovascular Care and Prevention Center	San Francisco	California
United States	University of California	San Francisco	California
United States	Stanford Hospital and Clinics Investigational Pharmacy	Stanford	California
United States	Stanford University Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Hong Kong,  Italy,  Japan,  Netherlands,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular-related mortality	Cardiovascular-related mortality	Baseline to Month 60
Other	All-cause hospitalization	Frequency of all-cause hospitalization	Baseline to Month 60
Other	Cardiovascular-related hospitalization	Frequency of cardiovascular-related hospitalization	Baseline to Month 60
Other	Kansas City Cardiomyopathy Questionnaire	Change from baseline at each visit in Kansas City Cardiomyopathy Questionnaire	Baseline to Month 60
Other	New York Heart Association classification	New York Heart Association (NYHA) classification at each visit	Baseline to Month 60
Other	Body Mass Index/modified Body Mass Index	Change from baseline in Body Mass Index/modified Body Mass Index at each visit	Baseline to Month 60
Other	Cardiac biomarkers	Change from baseline in NT-proBNP concentration at each visit	Baseline to Month 60
Other	Cardiac biomarkers	Change from baseline in Troponin I concentration at each visit	Baseline to Month 60
Primary	All-cause mortality and incidence of treatment emergent adverse events	Safety endpoints for analysis of the treatment groups	Baseline to Month 60

External Links

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