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Metabolske intervensjoner for å løse ikke-alkoholisk Steatohepatitt (NASH) med fibrose (MIRNA) (MIRNA)

2. april 2024 oppdatert av: Pfizer

EN FASE 2, RANDOMISERT, DOBBELT-BLINDT, DOBBEL-DUMMY, PLACEBO-KONTROLLERT, DOSESEGENDE, DOSEFINNENDE, PARALLELL GRUPPESTUDIE FOR Å VURDERE EFFEKTIVITETEN OG SIKKERHETEN TIL PF-06865571 (DGMINST OG 1 HJEMME OG 4-0 MED 4-0-0 ACCI) HOS VOKSNE DELTAKERE MED BIOPSIBEKRETTE IKKE-ALKOHOLISKE STEATOHEPATITT OG FIBROSIS Trinn 2 ELLER 3

Studien tar sikte på å evaluere to, oralt administrerte, undersøkelsesmidler - PF-06865571 (DGAT2-hemmer) og samtidig administrering av PF-06865571 med PF-05221304 (ACC-hemmer). Denne studien er spesielt utformet for å evaluere effekten av en rekke doser av DGAT2i alene, og DGAT2i + ACCi, på oppløsning av NASH eller forbedring av leverfibrose, vurdert histologisk (via leverbiopsi).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

258

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • Mhat Dr. Tota Venkova Ad
      • Plovdiv, Bulgaria, 4002
        • MHAT Medline Clinic AD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic MHAT Tokuda EAD
      • Sofia, Bulgaria, 1431
        • DCC Alexandrovska EOOD
      • Sofia, Bulgaria, 1431
        • UMHAT Alexandrovska EAD
      • Sofia, Bulgaria, 1431
        • Umhat Sv. Ivan Rilski Ead
      • Sofia, Bulgaria, 1797
        • UMHAT Sofiamed OOD
      • Stara Zagora, Bulgaria, 6001
        • MC New Rehabilitation Center EOOD
      • Varna, Bulgaria, 9020
        • DCC Mladost-M Varna OOD
      • Varna, Bulgaria, 9020
        • MC VIP Clinic OOD
  • Canada
      • Quebec, Canada, G1V 4T3
        • Diex Recherche Quebec Inc.
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary - Heritage Medical Research Clinic (HMRC)
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon and Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Health Authority QEII (Queen Elizabeth II) Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, N6A 2C2
        • Manna Research (London)
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Chicoutimi, Quebec, Canada, G7H 4J1
        • Resonance Magnetique du Saguenay-Lac-Saint-Jean
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H4A 3J1
        • Philips Radiation Oncology
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute of the MUHC
      • Montréal, Quebec, Canada, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85224
        • Institute for Liver Health DBA Arizona Liver Health
      • Gilbert, Arizona, Forente stater, 85233
        • Comprehensive Interventional Care Centers (CICC)
      • Glendale, Arizona, Forente stater, 85306
        • The Institute for Liver Health
      • Peoria, Arizona, Forente stater, 85381
        • The Institute for Liver Health
      • Sun City, Arizona, Forente stater, 85351
        • Comprehensive Interventional Care Centers (CICC)
      • Tucson, Arizona, Forente stater, 85712
        • Institute for Liver Health DBA Arizona Liver Health
    • California
      • Canoga Park, California, Forente stater, 91303
        • Hope Clinical Research
      • Coronado, California, Forente stater, 92118
        • Southern California Research Center
      • Coronado, California, Forente stater, 92118
        • Sharp Coronado Hospital
      • El Cajon, California, Forente stater, 92020
        • Magnolia Surgery Center
      • Encino, California, Forente stater, 91436
        • Encino Hospital Medical Center
      • Huntington Park, California, Forente stater, 90255
        • National Research Institute
      • La Jolla, California, Forente stater, 92037
        • Altman Clinical and Translational Research Institute (ACTRI)
      • La Jolla, California, Forente stater, 92037
        • Investigational Drug Service, Altman Clinical and Translational Research Institute (ACTRI)
      • La Jolla, California, Forente stater, 92037
        • University of California San Diego, Altman Clinical and Translational Research Institute Clinic
      • La Jolla, California, Forente stater, 92093
        • UCSD Altman Clinical and Transitional Research Institute
      • Lancaster, California, Forente stater, 93534
        • Om Research LLC
      • Lancaster, California, Forente stater, 93534
        • A V Pediatrics, Allergy & Family Medicine
      • Lancaster, California, Forente stater, 93534
        • Jatinder S. Pruthi, M.D. FACG CPI
      • Los Angeles, California, Forente stater, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Advanced Health Sciences Pavilion (Imaging)
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Comprehensive Transplant Center
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Medical Center Investigational Drug Services (Pharmacy)
      • Los Angeles, California, Forente stater, 90048
        • S. Mark Taper Foundation Imaging Center (Liver Biopsy)
      • Mission Hills, California, Forente stater, 91345
        • Providence Facey Medical Foundation
      • Mission Hills, California, Forente stater, 91345
        • Providence Holy Cross Medical Center
      • Montebello, California, Forente stater, 90640
        • ART Vascular
      • Monterey Park, California, Forente stater, 91754
        • ART Vascular
      • Murrieta, California, Forente stater, 92563
        • United Medical Doctors
      • Newport Beach, California, Forente stater, 92660
        • Back Bay Imaging (Liver Biopsy)
      • Palmdale, California, Forente stater, 93551
        • Advanced Imaging Center
      • Palo Alto, California, Forente stater, 94305
        • Stanford Hospital and Clinics
      • Palo Alto, California, Forente stater, 94304
        • Blake Wilbur Outpatient Clinic (MRI)
      • Pasadena, California, Forente stater, 91105
        • California Liver Research Institute
      • Pasadena, California, Forente stater, 91101
        • Huntington-Hill Imaging Center, Cordova
      • Pasadena, California, Forente stater, 91105
        • HMRI
      • Pasadena, California, Forente stater, 91105
        • Huntington Medical Research Institute
      • Pasadena, California, Forente stater, 91105
        • Huntington-Hill Imaging Center, Fair Oaks
      • Redwood City, California, Forente stater, 94063
        • Stanford Medicine Outpatient Center (Liver clinic/MRI)
      • Rialto, California, Forente stater, 92377
        • Inland Empire Clinical Trials, LLC
      • Sacramento, California, Forente stater, 95821
        • Clinical Trials Research
      • San Diego, California, Forente stater, 92114
        • Precision Research Institute
      • San Diego, California, Forente stater, 92120
        • WR-MCCR
      • San Diego, California, Forente stater, 92123-2731
        • Sharp and Children's MRI Center, LLC
      • San Jose, California, Forente stater, 95124
        • Stanford Cancer Center South Bay (MRI)
      • Tarzana, California, Forente stater, 91356
        • Liberty Pacific Advanced Imaging
      • Tustin, California, Forente stater, 92780
        • Orange County Research Center
      • Upland, California, Forente stater, 91786
        • Upland Clinical Research
    • Connecticut
      • Bristol, Connecticut, Forente stater, 06010
        • Bristol Hospital
      • Bristol, Connecticut, Forente stater, 06010
        • Bristol Radiology Center
      • Bristol, Connecticut, Forente stater, 06010
        • Connecticut Clinical Research Institute, LLC
      • New Haven, Connecticut, Forente stater, 06510
        • Yale New Haven Hospital
      • New Haven, Connecticut, Forente stater, 06511
        • Yale New Haven Hospital, Saint Raphael Campus (MRE location)
      • New Haven, Connecticut, Forente stater, 06519
        • Yale Center for Clinical Investigators, Church Street South Research Unit (CSRU)
      • New Haven, Connecticut, Forente stater, 06520
        • Yale Digestive Diseases (Fibroscan location)
    • Florida
      • Brandon, Florida, Forente stater, 33511
        • Tower Radiology (MRI-PDFF)
      • Brandon, Florida, Forente stater, 33511
        • Tower Radiology - Parsons
      • Clearwater, Florida, Forente stater, 33756
        • Gastro Florida
      • Clearwater, Florida, Forente stater, 33762
        • Gastro Florida
      • Doral, Florida, Forente stater, 33122
        • Integrity Clinical Research, LLC
      • Jacksonville, Florida, Forente stater, 32224
        • Mayo Clinic Florida
      • Lakewood Ranch, Florida, Forente stater, 34211
        • Florida Research Institute
      • Lakewood Ranch, Florida, Forente stater, 34202
        • FDHS Pathology Lab
      • Maitland, Florida, Forente stater, 32751
        • Center for Advanced Gastroenterology
      • Maitland, Florida, Forente stater, 32751
        • Sandlake Imaging
      • Miami, Florida, Forente stater, 33142
        • Acevedo Clinical Research Associates
      • Miami, Florida, Forente stater, 33125
        • Optimus U Corporation
      • Miami, Florida, Forente stater, 33137
        • Unique Imaging (Biscayne Imaging Center)
      • Miami, Florida, Forente stater, 33155
        • Ivetmar Medical Group LLC
      • Miami, Florida, Forente stater, 33156
        • Vascular and Interventional Specialists of Florida (Liver Biopsy)
      • Miami, Florida, Forente stater, 33175
        • Care Research Center Inc
      • Miami Lakes, Florida, Forente stater, 33014
        • San Marcus Research Clinic, Inc.
      • Oldsmar, Florida, Forente stater, 34677
        • TGH Imaging Powered by Tower Radiology Center (MRI)
      • Orlando, Florida, Forente stater, 32801
        • Clinical Neuroscience Solutions, Inc
      • Orlando, Florida, Forente stater, 32808
        • Omega Research Maitland, LLC
      • Palmetto Bay, Florida, Forente stater, 33157
        • Innovation Medical Research Center, Inc
      • Saint Petersburg, Florida, Forente stater, 33702
        • GCP, Global Clinical Professionals
      • Saint Petersburg, Florida, Forente stater, 33712
        • Gateway (Ultrasound)
      • Sarasota, Florida, Forente stater, 34239
        • Partners Imaging Center
      • Tampa, Florida, Forente stater, 33606
        • Radiology Associates
      • Tampa, Florida, Forente stater, 33613
        • Center For Clinical Studies
      • Zephyrhills, Florida, Forente stater, 33541
        • AdventHealth Zephyrhills
      • Zephyrhills, Florida, Forente stater, 33542
        • Florida Medical Clinic, LLC
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Atlanta Hospital
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Atlanta Hospital/Piedmont Transplant Institute
      • Columbus, Georgia, Forente stater, 31904
        • Columbus Regional Research Institute
      • Sandy Springs, Georgia, Forente stater, 30328
        • WR-Mount Vernon Clinical Research, LLC
      • Snellville, Georgia, Forente stater, 30078
        • Tekton Research, Inc.
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rush University Medical Center
    • Indiana
      • Brownsburg, Indiana, Forente stater, 46112
        • Investigators Research Group, LLC
      • Hendricks, Indiana, Forente stater, 46122
        • Hendricks Regional Health
    • Iowa
      • Clive, Iowa, Forente stater, 50325
        • Iowa Digestive Disease Center
      • Clive, Iowa, Forente stater, 50325
        • Heartland Medical Research, Inc. (Administrative Only)
      • Clive, Iowa, Forente stater, 50325
        • Iowa Radiology
      • Des Moines, Iowa, Forente stater, 50314
        • MercyOne Des Moines Medical Center (Mercy Medical Center)
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hospitals and Clinics
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Magnetic Resonance Research Facility
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • Kansas Medical Clinic PA
      • Wichita, Kansas, Forente stater, 67205-1138
        • Alliance for Multispecialty Research, LLC
      • Wichita, Kansas, Forente stater, 67226
        • Cypress Interventional
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70601
        • Centex Studies, Inc.
      • Lake Charles, Louisiana, Forente stater, 70601
        • Lake Charles Memorial Hospital
      • Marrero, Louisiana, Forente stater, 70072
        • Metropolitan Gastroenterology Associates
      • Marrero, Louisiana, Forente stater, 70072
        • Tandem Clinical Research GI, LLC
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, Forente stater, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Catonsville, Maryland, Forente stater, 21228
        • Gastro Health Research
      • Columbia, Maryland, Forente stater, 21045
        • Gastro Center of Maryland
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Michigan Clinical Research Unit (MCRU)
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
      • Flint, Michigan, Forente stater, 48504
        • Aa Mrc Llc
      • Grand Rapids, Michigan, Forente stater, 49503
        • Mercy Health
      • Grand Rapids, Michigan, Forente stater, 49505
        • M1 Imaging Center
      • Wyoming, Michigan, Forente stater, 49519
        • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • Jefferson City, Missouri, Forente stater, 65109
        • Jefferson City Medical Group, P.C.
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Sierra Clinical Research
      • Las Vegas, Nevada, Forente stater, 89113
        • Las Vegas Medical Research
      • Las Vegas, Nevada, Forente stater, 89104
        • Desert Radiology
      • Las Vegas, Nevada, Forente stater, 89104
        • Machuca Family Medicine
      • Las Vegas, Nevada, Forente stater, 89104
        • The Machuca Foundation, Inc.
      • Las Vegas, Nevada, Forente stater, 89118
        • Pueblo Medical Imaging
    • New Jersey
      • Hillsborough, New Jersey, Forente stater, 08844
        • Digestive Healthcare Associates
      • Hillsborough, New Jersey, Forente stater, 08844
        • University Radiology
      • Raritan, New Jersey, Forente stater, 08869
        • Amici Clinical Research
    • New York
      • Manhasset, New York, Forente stater, 11030
        • Northwell Health Center for Liver Diseases
      • New York, New York, Forente stater, 10003
        • Mount Sinai Downtown Union Square
      • New York, New York, Forente stater, 10003
        • Icahn School of Medicine at Mount Sinai Beth Israel
      • New York, New York, Forente stater, 10029
        • Hess Building- CMS
      • New York, New York, Forente stater, 10029
        • Icahn School of Medicine at Mount Sinai/The Mount Sinai Hospital
      • New York, New York, Forente stater, 10029
        • The Mount Sinai Hospital: Department of Pharmacy
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 26712
        • M3-Wake Research, Inc.
      • Winston-Salem, North Carolina, Forente stater, 27103
        • PMG Research of Winston-Salem, LLC
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Gastroenterology Associates of the Piedmont, PA
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Novant Health Medical Center
    • Ohio
      • Middleburg Heights, Ohio, Forente stater, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Digestive Disease Specialists, Inc.
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Comprehensive Diagnostic Imaging
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Digestive Disease Specialists, Inc. Endoscopy Lab
      • Oklahoma City, Oklahoma, Forente stater, 73134
        • Oklahoma Spine Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC - Center for Liver Diseases in the Digestive Disorders Clinic
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC - Translational Research Center
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Presbyterian Shadyside; Presbyterian Campus Pharmacy
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02905
        • University Gastroenterology
      • Providence, Rhode Island, Forente stater, 02908
        • Roger Williams Hospital
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • MUSC- Ashley River Tower
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37421
        • WR-ClinSearch, LLC
      • Chattanooga, Tennessee, Forente stater, 37421
        • Chattanooga Imaging Center
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center - Digestive Disease Center
      • Nashville, Tennessee, Forente stater, 37211
        • Quality Medical Research, PLLC
      • Nashville, Tennessee, Forente stater, 37212-1610
        • Vanderbilt University Medical Center - GI Research Office
      • Nashville, Tennessee, Forente stater, 37212
        • Vanderbilt Hepatology and Liver Transplant
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center - Heart Station
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center - Interventional Radiology
    • Texas
      • Addison, Texas, Forente stater, 75001
        • Texas Center for Interventional Surgery (Liver Biopsy Facility)
      • Arlington, Texas, Forente stater, 76012
        • Texas Clinical Research Institute
      • Dallas, Texas, Forente stater, 75203
        • The Liver Institute At Methodist Dallas Medical Center
      • Dallas, Texas, Forente stater, 75203
        • Methodist Dallas Medical Center (Liver Biopsy)
      • Dallas, Texas, Forente stater, 75203
        • Methodist Dallas Medical Center (MRI-PDFF)
      • Dallas, Texas, Forente stater, 75246
        • Touchstone Imaging
      • DeSoto, Texas, Forente stater, 75115
        • Center For Diagnostic Imaging
      • Fort Worth, Texas, Forente stater, 76104
        • GI Alliance
      • Houston, Texas, Forente stater, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, Forente stater, 77058
        • Centex Studies, Inc.
      • Houston, Texas, Forente stater, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, Forente stater, 77084
        • Premier Vein and Vascular
      • McAllen, Texas, Forente stater, 78504
        • Centex Studies, Inc
      • Pearland, Texas, Forente stater, 77584
        • HCA Houston Healthcare Pearland
      • San Antonio, Texas, Forente stater, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, Forente stater, 78215
        • American Research Corporation at the Texas Liver Institute
      • San Antonio, Texas, Forente stater, 78229
        • Diabetes and Glandular Disease Clinic, P.A.
      • Sugar Land, Texas, Forente stater, 77479
        • Reddy Cardiac Wellness
      • Waco, Texas, Forente stater, 76710
        • Impact Research Institute
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Gastro Health Research
      • Manassas, Virginia, Forente stater, 20110
        • Manassas Clinical Research Center
      • Norfolk, Virginia, Forente stater, 23502
        • Digestive and Liver Disease Specialists
      • Norfolk, Virginia, Forente stater, 23502
        • Sentara Leigh Hospital
      • Richmond, Virginia, Forente stater, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, Forente stater, 23249
        • McGuire VA Medical Center
      • Richmond, Virginia, Forente stater, 23298-5051
        • VCU Medical Center Investigational Drug Service
      • Suffolk, Virginia, Forente stater, 23435
        • Virginia Gastroenterology Clinical Research
    • Washington
      • Seattle, Washington, Forente stater, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center
      • Seattle, Washington, Forente stater, 98105
        • Liver Institute Northwest
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center
      • Seattle, Washington, Forente stater, 98104
        • Harborview Medical Center Investigational Drug Services
      • Seattle, Washington, Forente stater, 98104
        • Seattle Radiology
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
  • India
      • Gurugram, India, 122001
        • Medanta - The Medicity
      • New Delhi, India, 110 070
        • Institute of Liver and Biliary Sciences (ILBS)
      • New Delhi, India, 110029
        • All India Institute Of Medical Sciences (AIIMS)
    • Gujarat
      • Surat, Gujarat, India, 395009
        • Gujarat Hospital - Gastro and Vascular Centre
      • Surat, Gujarat, India, 395002
        • Surat Institute of Digestive Sciences
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Global Hospital - Super Speciality & Transplant Centre
    • NEW Delhi
      • Saket, NEW Delhi, India, 110017
        • Max Smart Super Speciality Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • S.M.S. Medical College & Hospital
    • WEST Bengal
      • Kolkata, WEST Bengal, India, 700020
        • Institute of Post Graduate Medical Education and Research & SSKM Hospital
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Gifu, Japan, 500-8513
        • Gifu Municipal Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Miyazaki, Japan, 880-0003
        • Miyazaki Medical Center Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Gifu
      • Ogaki, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japan, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Shinshu University Hospital
    • Nagasaki
      • Ohmura, Nagasaki, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center
    • Osaka
      • Sakai, Osaka, Japan, 591-8025
        • Osaka Rosai Hospital
      • Suita, Osaka, Japan, 564-0013
        • Saiseikai Suita Hospital
    • Shizuoka
      • Izunokuni, Shizuoka, Japan, 410-2295
        • Juntendo University Shizuoka Hospital
  • Kina
      • Beijing, Kina, 100044
        • Peking University People's Hospital
      • Beijing, Kina, 102218
        • Beijing Tsinghua Changgung Hospital
      • Beijing, Kina, 100069
        • Beijing YouAn Hosptial,Capital Medical University
      • Tianjin, Kina, 300170
        • Tianjin Third Central Hospital
      • Tianjin, Kina, 300192
        • Tianjin Second People's Hospital
    • Beijing
      • Beijing, Beijing, Kina, 100050
        • Beijing Friendship Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050051
        • The Third Hospital of Hebei Medical University
    • Hunan
      • Changsha, Hunan, Kina, 410005
        • Hunan Provincial People's Hospital
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • The First Bethune Hospital of Jilin University
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750004
        • General Hospital of Ningxia Medical University
    • Shandong
      • Qingdao, Shandong, Kina, 266042
        • Qingdao Central Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310000
        • The Affiliated Hospital of Hangzhou Normal University
      • Wenzhou, Zhejiang, Kina, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Korea, Republikken
      • Busan, Korea, Republikken, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republikken, 42415
        • Yeungnam University Hospital
      • Daegu, Korea, Republikken, 41944
        • Kyungpook National University Hospital
      • Seoul, Korea, Republikken, 03722
        • Severance Hospital Yonsei University Health System
    • Seoul
      • Dongjak-gu, Seoul, Korea, Republikken, 07061
        • SMG-SNU Boramae Medical Center
  • Polen
      • Katowice, Polen, 40-211
        • Szpital Zakonu Bonifratrow
      • Katowice, Polen, 40-748
        • NZOZ Vita Longa Sp. z o.o.
      • Katowice, Polen, 40-752
        • Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
      • Komorowice, Polen, 52-229
        • Orthos Szpital Wielospecjalistyczny Sp. z o.o. (Liver Biopsy)
      • Krakow, Polen, 30-688
        • SPZOZ Szpital Uniwersytecki w Krakowie
      • Krakow, Polen, 31-061
        • Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie sp. z o.o. (Liver Biopsy)
      • Krakow, Polen, 31-501
        • Krakowskie Centrum Medyczne
      • Lodz, Polen, 91-347
        • Wojewodzki Specjalistyczny Szpital im. Dr. Wl. Bieganskiego w Lodzi
      • Myslowice, Polen, 41-400
        • ID Clinic
      • Warszawa, Polen, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Wroclaw, Polen, 50-088
        • FutureMeds Sp. z o.o.
      • Zamosc, Polen, 22-400
        • ETG Zamosc
      • Zamosc, Polen, 22-400
        • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
      • Zamosc, Polen, 22-400
        • ETG Zamo??
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group PSC
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
      • San Juan, Puerto Rico, 00927
        • FDI Clinical Research
  • Slovakia
      • Banska Bystrica, Slovakia, 974 01
        • Fakultna Nemocnica s Poliklinikou F. D. Roosevelta Banska Bystrica
      • Bratislava, Slovakia, 851 01
        • Medispektrum, s.r.o
      • Bratislava - Mestska Cast Nove Mesto, Slovakia, 831 01
        • Summit Clinical Research, s.r.o.
      • Bratislava - Mestska Cast Ruzinov, Slovakia, 831 04
        • Lama Medical Care s.r.o.
      • Kosice - Mestska Cast Zapad, Slovakia, 040 11
        • Univerzitna nemocnica L. Pasteura Kosice
      • Nitra, Slovakia, 949 01
        • KM Management spol. s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
      • Nitra, Slovakia, 950 01
        • Fakultná nemocnica Nitra
      • Trnava, Slovakia, 917 01
        • JAL, s.r.o.
  • Taiwan
      • Chia-Yi, Taiwan, 600
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University (NCKU) Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
    • Changhua County
      • Changhua City, Changhua County, Taiwan, 500
        • Changhua Christian Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Biopsipåvist NASH med enten F2- eller F3-fibrose, i henhold til NASH CRN-definisjon
  • BMI >/= 22,5 kg/m2

Ekskluderingskriterier:

  • Bevis på andre årsaker til leversykdom som alkoholisk steatohepatitt, (de)kompensert cirrhose, aktiv viral hepatitt
  • Enhver tilstand som muligens påvirker legemiddelabsorpsjonen - Ustabile samtidige medisinske tilstander, basert på medisinsk historie eller screeningslaboratorieresultater inkludert-
  • ustabile leverfunksjonstester, nylig(e) kardiovaskulære hendelser, signifikante maligniteter,

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
deltakerne får medisiner i 48 uker
Legemiddel: Placebo
Tablett
Eksperimentell: PF-06865571 25 milligram (mg) to ganger daglig (BID)
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Eksperimentell: PF-06865571 75 mg BID
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Eksperimentell: PF-06865571 150 mg BID
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Eksperimentell: PF-06865571 300 mg BID
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Eksperimentell: PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Legemiddel: PF-05221304
Tablett
Eksperimentell: PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)
deltakerne får medisiner i 48 uker
Legemiddel: PF-06865571
Tablett
Legemiddel: PF-05221304
Tablett

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oppløsning av NASH uten forverring av fibrose eller forbedring av fibrose med 1>/= eller begge deler
Tidsramme: Uke 48
Andel deltakere som oppnår oppløsning av NASH uten forverring av fibrose eller forbedring av fibrose med ≥1 stadium uten forverring av NASH eller begge deler
Uke 48

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentvis endring i leverfett
Tidsramme: Uke 48
Prosentvis endring i leverfett (vurdert via MR-PDFF)
Uke 48
Andel deltakere som oppnår oppløsning av NASH, uten forverring av fibrose
Tidsramme: Uke 48
Uke 48
Andel deltakere som oppnår bedring i fibrose innen ≥1 stadium, uten forverring av NASH
Tidsramme: Uke 48
Uke 48
Andel deltakere med forbedring av fibrose med ≥2 stadier, uten forverring av NASH
Tidsramme: Uke 48
Uke 48
Andel deltakere med forbedring på ≥2 poeng i Total NASH
Tidsramme: Uke 48
Uke 48
Andel deltakere med en klinisk signifikant endring fra baseline i vitale tegn
Tidsramme: Grunnlinje til uke 50
Grunnlinje til uke 50
Andel deltakere med en klinisk signifikant endring fra baseline i laboratorieverdier
Tidsramme: Grunnlinje til uke 50
Grunnlinje til uke 50
Andel deltakere med en klinisk signifikant endring fra baseline i elektrokardiogrammer (EKG) parametere
Tidsramme: Grunnlinje til uke 50
Grunnlinje til uke 50
Andel deltakere med behandlingsfremkallende bivirkninger (TEAE)
Tidsramme: Grunnlinje til uke 52
Grunnlinje til uke 52

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2020

Primær fullføring (Faktiske)

23. januar 2024

Studiet fullført (Faktiske)

21. februar 2024

Datoer for studieregistrering

Først innsendt

23. mars 2020

Først innsendt som oppfylte QC-kriteriene

23. mars 2020

Først lagt ut (Faktiske)

25. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2024

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. april 2024

Sist bekreftet

1. april 2024

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C2541013
  • 2019-004775-39 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Ikke-alkoholisk fettleversykdom

Kliniske studier på Placebo

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Singapore

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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