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Een onderzoek naar ARRY-371797 (PF-07265803) bij patiënten met symptomatische gedilateerde cardiomyopathie als gevolg van een laminaire A/C-genmutatie

EEN FASE 3, MULTINATIONALE, GERANDOMISEERDE, PLACEBO-GECONTROLEERDE STUDIE VAN ARRY-371797 (PF-07265803) BIJ PATINTEN MET SYMPTOMATISCHE DILATED CARDIOMYOPATHIE ALS GEVOLG VAN EEN LAMIN A/C GEN MUTATIE

Sponsors

Hoofdsponsor: Pfizer

Bron Pfizer
Korte samenvatting

Dit is een gerandomiseerde, dubbelblinde, placebo-gecontroleerde studie bij patiënten met gedilateerde cardiomyopathie (DCM) als gevolg van een mutatie van het gen dat codeert voor het lamin A/C-eiwit (LMNA). de onderzoek zal dosisniveau van het onderzoeksgeneesmiddel (ARRY) voorlopige werking en veiligheid bij deze patiëntenpopulatie. Nadat de primaire analyse heeft uitgevoerd, kunnen een open-label behandeling krijgen met ARRY-371797.

Algemene status Werving
Startdatum 2018-04-17
einddatum 2024-05-28
Primaire voltooiingsdatum 2023-11-15
Fase Fase 3
Studietype Interventionele
Primaire uitkomst
Meten Tijdsspanne
Verandering vanaf baseline in 6 minuten looptest (6MWT) in week 24
Secundair resultaat
Meten Tijdsspanne
Change from baseline in 6-minute walk test (6MWT) at Weeks 4 and 12
Verandering ten opzichte van baseline in het Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL)-domein in week 12 en 24
Verandering ten opzichte van baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) zoals gemeten door Total Symptom Score (TSS)-domein in week 12 en 24
Verandering ten opzichte van baseline in Patient Global Impression score of Severity (PGI-S) van hartfalensymptomen en beperkingen van lichamelijke activiteit in week 12 en 24
Verandering t.o.v. baseline in Patient Global Impression Score of Change (PGI-C) in hartfalensymptomen en fysieke activiteitsbeperkingen in week 12 en 24
Verandering vanaf baseline in N-terminaal pro-brain natriuretisch peptide (NT-proBNP) in week 4, 12 en 24
Evalueer de impact van ARRY-371797 (PF-07265803) op het samengestelde eindpunt van mortaliteit door alle oorzaken of verergering van hartfalen (WHF). Van randomisatie tot 60 maanden.
Evalueer de impact van ARRY-371797 (PF-07265803) op de totale overleving (OS). Van randomisatie tot 60 maanden.
Evalueer de veiligheid van ARRY-371797 (PF-07265803). Van randomisatie tot 60 maanden.
Inschrijving 160
Staat
Interventie

Type interventie: Drug

Interventienaam: ARRY-371797 (PF-07265803)

Omschrijving: 400 mg twice daily (BID)

Type interventie: Ander

Interventienaam: Placebo

Omschrijving: BOD

Armgroeplabel: Deel 1 Dubbelblinde behandeling

Geschiktheid

Criteria:

Geselecteerde belangrijke opnamecriteria: - Patiënten met symptomatische lamin A/C-eiwit (LMNA)-gerelateerde cardiomyopathie Klasse II/III/ van klasse IV wordt ook beschreven: - Genpositief voor een pathogene, waarschijnlijk pathogene of VUS-mutatie in het LMNA-gen as bepaald door een geaccrediteerd klinisch laboratorium. - Bewijs van hartfunctiestoornis bij LVEF

Geslacht:

allemaal

Minimum leeftijd:

18 jaar

Maximale leeftijd:

Nvt

Gezonde vrijwilligers:

Nee

Algemeen ambtenaar
Achternaam Rol Verbondenheid
Pfizer Pfizer CT.gov Call Center Study Director Pfizer
Algemeen contact Contactgegevens worden alleen weergegeven wanneer het onderzoek proefpersonen werft.
Plaats
Faciliteit: Toestand:
University of Alabama at Birmingham Hospital | Birmingham, Alabama, 35233, United States Recruiting
University of Alabama at Birmingham the Kirklin Clinic | Birmingham, Alabama, 35233, United States Recruiting
IDS Pharmacy at UAB Hospital | Birmingham, Alabama, 35249, United States Recruiting
Cardiovascular Clinical Trials Unit | Birmingham, Alabama, 35294, United States Recruiting
Chandler Regional Medical Center | Chandler, Arizona, 85224, United States Active, not recruiting
Valley Heart Rhythm Specialists, PLLC | Chandler, Arizona, 85224, United States Active, not recruiting
Cardiovascular and Stem Cell Consultants | Gilbert, Arizona, 85297-0425, United States Active, not recruiting
Cardiovascular Research Clinic | Gilbert, Arizona, 85297-0425, United States Active, not recruiting
Dignity Health, Mercy Gilbert Medical Center | Gilbert, Arizona, 85297-0425, United States Active, not recruiting
Mercy Gilbert Medical Center | Gilbert, Arizona, 85297, United States Active, not recruiting
Children's Clinic | Tucson, Arizona, 85712, United States Recruiting
Banner - Banner University Medical Center South | Tucson, Arizona, 85713, United States Recruiting
Banner - University Medical Center Tucson | Tucson, Arizona, 85719, United States Recruiting
Banner University Medicine North | Tucson, Arizona, 85719, United States Recruiting
Banner University Medical Center Tuscon | Tucson, Arizona, 85724, United States Recruiting
University of Arizona Sarver Heart Center | Tucson, Arizona, 85724, United States Recruiting
Ahmanson Cardiomyopathy Center Cardiovascular Genetics | Los Angeles, California, 90095, United States Not yet recruiting
Clinical and Translational Research Unit (CTRU) | Palo Alto, California, 94304, United States Recruiting
Stanford Hospital and Clinics | Stanford, California, 94305, United States Recruiting
University of Colorado Academic Offices Building | Aurora, Colorado, 80045, United States Recruiting
University of Colorado Clinical and Translational Research Center | Aurora, Colorado, 80045, United States Recruiting
University of Colorado Hospital | Aurora, Colorado, 80045, United States Recruiting
Medstar Washington Hospital Center | Washington, District of Columbia, 20010, United States Not yet recruiting
Innovative Research of West Florida | Clearwater, Florida, 33756, United States Active, not recruiting
University of South Florida | Tampa, Florida, 33606-3601, United States Recruiting
USF Health | Tampa, Florida, 33606, United States Recruiting
Florida Cardiovascular Institute PA | Tampa, Florida, 33609, United States Recruiting
Centers for Heart Failure Therapy | Atlanta, Georgia, 30322, United States Recruiting
Emory University Hospital | Atlanta, Georgia, 30322, United States Recruiting
Columbus Cardiology Associates Research - IACT - HyperCore - PPDS | Columbus, Georgia, 31904-6877, United States Recruiting
St Luke's Idaho Cardiology Associates Heart Rhythm Center | Boise, Idaho, 83702, United States Recruiting
St Luke's Health System | Boise, Idaho, 83712, United States Recruiting
St Luke's Idaho Cardiology Associates - Heart Failure Clinic | Meridian, Idaho, 83642, United States Recruiting
St Luke's Idaho Cardiology Associates -Meridian | Meridian, Idaho, 83642, United States Recruiting
Brigham and Women's Hospital | Boston, Massachusetts, 02115, United States Recruiting
MidMichigan Medical Center Midland | Midland, Michigan, 48670, United States Recruiting
Washington University Center For Advanced Medicine | Saint Louis, Missouri, 63110, United States Recruiting
Washington University Center for Outpatient Health | Saint Louis, Missouri, 63110, United States Recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting
Rutgers New Jersey Medical School - Doctors Office Center | Newark, New Jersey, 07103, United States Not yet recruiting
Newark Beth Israel Medical Center | Newark, New Jersey, 07112, United States Active, not recruiting
NYU School of Medicine / NYU Langone Health | New York, New York, 10016, United States Recruiting
Columbia University Medical Center/New York Presbyterian Hospital | New York, New York, 10032, United States Recruiting
Columbia University/Presbyterian Hospital - Vivian & Seymour Milstein Family Heart Center | New York, New York, 10032, United States Recruiting
The Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Recruiting
Ohio State University Wexner Medical Center | Columbus, Ohio, 43210, United States Recruiting
The Ohio State University Wexner Medical Center - Ross Heart Hospital | Columbus, Ohio, 43210, United States Recruiting
The Ohio State University Wexner Medical Center - University Hospital | Columbus, Ohio, 43210, United States Recruiting
OHSU Research Pharmacy Services | Portland, Oregon, 97239, United States Not yet recruiting
Oregon Health & Science University | Portland, Oregon, 97239, United States Not yet recruiting
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) | Philadelphia, Pennsylvania, 19104, United States Recruiting
Medical University of South Carolina - PPDS | Charleston, South Carolina, 29425-8911, United States Recruiting
Medical University of South Carolina - PPDS | Charleston, South Carolina, 29425, United States Recruiting
Stern Cardiovascular Foundation Inc | Germantown, Tennessee, 38138, United States Recruiting
Tennessee Center for Clinical Trials | Tullahoma, Tennessee, 37388, United States Recruiting
Baylor Scott and White Heart and Vascular Hospital | Dallas, Texas, 75226, United States Recruiting
Baylor Annette C and Harold C Simmons Transplant Institute | Dallas, Texas, 75246, United States Recruiting
Baylor Scott and White Research Institute | Temple, Texas, 76508, United States Recruiting
Intermountain Medical Center | Murray, Utah, 84107, United States Recruiting
University of Washington Medical Center | Seattle, Washington, 98195, United States Recruiting
Fundacion Favaloro para la Docencia e Investigacion Medica | Buenos Aires, Ciudad Autónoma DE Buenos Aires, C1093AAS, Argentina Recruiting
Instituto CAICI | Rosario, Santa FE, S2000 PBJ, Argentina Recruiting
Hospital Provincial Del Centenario | Rosario, Santa FE, S2000KDS, Argentina Recruiting
Hospital Británico de Buenos Aires | Buenos Aires, C1280AEB, Argentina Active, not recruiting
Hospital Provincial Dr Jose Maria Cullen | Santa Fe, S3000EOZ, Argentina Active, not recruiting
Onze-Lieve-Vrouwziekenhuis | Aalst, Oost-vlaanderen, 9300, Belgium Recruiting
UZ Leuven | Leuven, 3000, Belgium Recruiting
St. Paul's Hospital | Vancouver, British Columbia, V6Z 1Y6, Canada Active, not recruiting
Nova Scotia Health Authority (Capital District Health Authority) | Halifax, Nova Scotia, B3H 1V7, Canada Recruiting
NSHA QEII Health Sciences Halifax Infirmary | Halifax, Nova Scotia, B3H 3A7, Canada Recruiting
University of Ottawa Heart Institute | Ottawa, Ontario, K1Y 4W7, Canada Recruiting
Kawartha Cardiology Clinical Trials | Peterborough, Ontario, K9J 0B2, Canada Recruiting
Clinical Laboratories of Montreal Heart Institute | Montreal, Quebec, H1T 1C8, Canada Recruiting
Centre Intégré Universitaire de santé et de services sociaux de l'Estrie Centre hospitalier | Sherbrooke, Quebec, J1G 2E8, Canada Recruiting
Ospedale Di Cattinara | Trieste, Friuli-venezia Giulia, 34149, Italy Recruiting
Azienda Ospedaliera Sant'Andrea | Roma, Lazio, 00189, Italy Recruiting
Ospedale Santa Maria Della Misericordia Perugia | Perugia - Località S. Andrea Delle Fratte, Perugia, 6132, Italy Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia, PV, 27100, Italy Recruiting
Azienda Ospedaliera Universitaria Careggi | Firenze, Toscana, 50134, Italy Recruiting
A.O.U. di Perugia Ospedale Santa Maria della Misericordia | Perugia, Umbria, 06156, Italy Recruiting
AO Ospedale Policlinico Consorziale di Bari | Bari, 70124, Italy Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari, 70124, Italy Recruiting
Azienda Ospedaliera Spedali Civili di Brescia | Brescia, 25123, Italy Active, not recruiting
Azienda Ospedaliera Universitaria Careggi | Firenze, 50134, Italy Recruiting
IRCCS Pavia - Istituti Clinici Scientifici Maugeri Spa ? Società Benefit | Pavia, 27100, Italy Recruiting
Presidio Ospedaliero Madonna del Soccorso | San Benedetto del Tronto, 63074, Italy Recruiting
Hospital Boutique Riobamba | Ciudad de Mexico, Distrito Federal, 07300, Mexico Active, not recruiting
Cardiolink Clin Trials S.C. | Monterrey, Nuevo LEÓN, 64060, Mexico Active, not recruiting
Christus Muguerza Hospital Alta Especialidad | Monterrey, Nuevo LEÓN, 64060, Mexico Active, not recruiting
Fundación de Atención e Investigación Médica Lindavista S.C. | Ciudad de México, 07300, Mexico Active, not recruiting
Amsterdam UMC, Location Academic Medical Center | Amsterdam, Noord-holland, 1105 AZ, Netherlands Recruiting
Sykehuset Innlandet HF Hamar | Hamar, 2318, Norway Recruiting
Oslo Universitetssykehus HF Rikshospitalet | Oslo, N-0424, Norway Recruiting
Centro de Farmacovigilancia de Galicia | Santiago de Compostela, A Coruña, 15781, Spain Recruiting
Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda, Madrid, 28222, Spain Recruiting
Hospital Universitario Virgen de la Arrixaca | El Palmar, Murcia, 30120, Spain Recruiting
Complejo Hospitalario Universitario de Vigo - H. Alvaro Cunqueiro | Vigo, Pontevedra, 36312, Spain Recruiting
Complexo Hospitalario Universitario A Coruña | A Coruna, 15006, Spain Recruiting
Hospital Universitario Vall d'Hebrón - PPDS | Barcelona, 08035, Spain Recruiting
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Recruiting
Hospital General Universitario Reina Sofia | Cordoba, 14004, Spain Recruiting
C.H. Regional Reina Sofia - PPDS | Córdoba, 14004, Spain Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda, 28222, Spain Recruiting
Hospital Universitario Son Llatzer | Palma de Mallorca, 07198, Spain Recruiting
Queen Elizabeth University Hospital - PPDS | Glasgow, Glasgow CITY, G51 4TF, United Kingdom Recruiting
St Bartholomew's Hospital | London, EC1A 7BE, United Kingdom Recruiting
Royal Brompton Hospital | London, SW3 6NP, United Kingdom Recruiting
Locatie Landen

Argentina

Belgium

Canada

Italy

Mexico

Netherlands

Norway

Spain

United Kingdom

United States

Verificatiedatum

2021-11-01

Verantwoordelijke partij

Type: Sponsor

Sleutelwoorden
Heeft uitgebreide toegang Nee
Aantal wapens 2
Arm groep

Label: Part 1 Double-blind Treatment

Type: Experimental

Omschrijving: ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally

Label: Deel 2 Open-label behandeling

Type: experimenteel

Omschrijving: ARRY-371797 (PF-07265803) tablet oraal;

Acroniem REALM-DCM
Bestudeer ontwerpinformatie

Toewijzing: gerandomiseerd

Interventiemodel: Parallelle toewijzing

Interventiemodel Beschrijving: Het onderzoek zal in 2 delen worden uitgevoerd: een gerandomiseerde, dubbelblinde behandelperiode van minimaal 24 weken, gevolgd door een ARRY-371797 (PF-07265803) open-label behandelperiode.

Primair doel: behandeling

Maskeren: Dubbel (deelnemer, onderzoeker)

Masking Beschrijving: Tijdens de gerandomiseerde, dubbelblinde periode blijven patiënten, onderzoekers, locatiepersoneel en het sponsorpersoneel dat direct betrokken is bij de uitvoering van het onderzoek, geblindeerd voor de behandeling, officiële wettelijke verplichtingen.

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