Phase
Condition
Liver Disease
Primary Biliary Cholangitis
Treatment
Resmetirom
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, andcompleted the Week 56 visit within 90 days of the Extension Day 1 visit, and arewilling to participate in MAESTRO-NAFLD-OLE and provide written informed consent.
For patients who screen failed MAESTRO-NASH, must provide written informed consentfor MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirementsfor MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLEand have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of theExtension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one ofthe following results:
NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0,with F1B, F2 or F3
NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, butineligible for MAESTRO-NASH)
Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH andbaseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD <12,albumin ≥3.2, and bilirubin <2
For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, musthave documented CP-A/B (score <8) NASH cirrhosis (including minimal decompensation)and MELD <15 unless MELD >=15 based on non-cirrhotic parameters. MAESTRO-NASHOUTCOMES screen failures must have screened and met all eligibility requirements forMAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit forMAESTRO-NAFLD-OLE .
Exclusion
Exclusion Criteria:
A history of significant alcohol consumption for a period of more than 3 consecutivemonths within 1 year prior to Extension Day 1.
Diagnosis of hepatocellular carcinoma or other carcinomas that may preventparticipation in the Extension study.
Chronic liver diseases
Has an active autoimmune disease
Any other condition which, in the opinion of the Investigator, would impedecompliance, hinder completion of the study, compromise the well-being of thepatient, or interfere with the study outcomes.
Study Design
Connect with a study center
Fundacion de Investigacion de Diego
San Juan,
Puerto RicoSite Not Available
Central Research Associates
Birmingham, Alabama 35205
United StatesSite Not Available
Arizona Liver Health - Chandler
Chandler, Arizona 85224
United StatesSite Not Available
East Valley Family Physicians
Chandler, Arizona 85224
United StatesSite Not Available
The Institute For Liver Health - Glendale
Glendale, Arizona 85306
United StatesSite Not Available
Adobe Gastroenterology
Tucson, Arizona 85712
United StatesSite Not Available
The Institute For Liver Health - Tucson
Tucson, Arizona 85711
United StatesSite Not Available
Arkansas Gastroenterology
North Little Rock, Arkansas 72117
United StatesSite Not Available
Fresno Clinical Research Center
Fresno, California 93720
United StatesSite Not Available
National Research Institute - Huntington Park
Huntington Park, California 90255
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
National Research Institute - Los Angeles
Los Angeles, California 90057
United StatesSite Not Available
Ruane Clinical Research Group
Los Angeles, California 90036
United StatesSite Not Available
Catalina Research Institute
Montclair, California 91763
United StatesSite Not Available
National Research Institute - Panorama City
Panorama City, California 91402
United StatesSite Not Available
San Fernando Valley Health Institute
West Hills, California 91307
United StatesSite Not Available
South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado 80113
United StatesSite Not Available
Excel Medical Clinical Trials
Boca Raton, Florida 33434
United StatesSite Not Available
Covenant Research
Fort Myers, Florida 33912
United StatesSite Not Available
Velocity Clinical Research, Hallandale Beach (MD Clinical)
Hallandale Beach, Florida 33009
United StatesSite Not Available
Floridian Clinical Research
Hialeah, Florida 33016
United StatesSite Not Available
Nature Coast Clinical Research - Inverness
Inverness, Florida 34452
United StatesSite Not Available
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United StatesSite Not Available
Florida Research Institute
Lakewood Ranch, Florida 34211
United StatesSite Not Available
Miami Dade Medical Research Institute
Miami, Florida 33176
United StatesSite Not Available
Orlando Research Center
Orlando, Florida 32806
United StatesSite Not Available
Progressive Medical Research
Port Orange, Florida 32127
United StatesSite Not Available
Covenant Research
Sarasota, Florida 34240
United StatesSite Not Available
The Villages Research Center
The Villages, Florida 32162
United StatesSite Not Available
Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
United StatesSite Not Available
East-West Medical Research Institute
Honolulu, Hawaii 96814
United StatesSite Not Available
Chicago Research Center
Chicago, Illinois 60602
United StatesSite Not Available
Northwestern Memorial Physicians Group
Chicago, Illinois 60611
United StatesSite Not Available
Iowa Diabetes Research
West Des Moines, Iowa 50265
United StatesSite Not Available
Kansas Medical Clinic - Gastroenterology
Topeka, Kansas 66606
United StatesSite Not Available
L-MARC Research Center
Louisville, Kentucky 40213
United StatesSite Not Available
Digestive Health Center of Louisiana
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Tandem Clinical Research - New Orleans Area Site
Marrero, Louisiana 70072
United StatesSite Not Available
Clinical Trials of America
West Monroe, Louisiana 71291
United StatesSite Not Available
Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi 39232
United StatesSite Not Available
Southern Therapy and Advanced Research
Jackson, Mississippi 39216
United StatesSite Not Available
Kansas City Research Institute
Kansas City, Missouri 64131
United StatesSite Not Available
Henderson Research Center
Henderson, Nevada 89052
United StatesSite Not Available
Clarity Clinical Research
East Syracuse, New York 13057
United StatesSite Not Available
Mount Sinai Health System
New York, New York 10029
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Cumberland Research Associates
Fayetteville, North Carolina 28304
United StatesSite Not Available
Diabetes and Endocrinology Consultants
Morehead City, North Carolina 28557
United StatesSite Not Available
Platinum - Sterling Research Group - Springdale
Cincinnati, Ohio 45246
United StatesSite Not Available
Aventiv Research Columbus
Columbus, Ohio 43213
United StatesSite Not Available
Awasty Research Network
Marion, Ohio 43302
United StatesSite Not Available
Premier Medical Group - Clarksville - Dunlop Lane
Clarksville, Tennessee 37040
United StatesSite Not Available
Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee 38138
United StatesSite Not Available
Pinnacle Clinical Research - Austin
Austin, Texas 78746
United StatesSite Not Available
Dallas Research Center
Dallas, Texas 75234
United StatesSite Not Available
Liver Center of Texas
Dallas, Texas 75234
United StatesSite Not Available
The Liver Institute At Methodist Dallas
Dallas, Texas 75203
United StatesSite Not Available
South Texas Research Institute
Edinburg, Texas 78539
United StatesSite Not Available
Texas Digestive Disease Consultants
Fort Worth, Texas 76104
United StatesSite Not Available
Liver Associates of Texas
Houston, Texas 77030
United StatesSite Not Available
Doctor's Hospital at Renaissance
McAllen, Texas 78504
United StatesSite Not Available
Plano Research Center
Plano, Texas 75093
United StatesSite Not Available
Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
San Antonio Research Center
San Antonio, Texas 78229
United StatesSite Not Available
Texas Liver Institute/American Research Corporation
San Antonio, Texas 78215
United StatesSite Not Available
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas 78666
United StatesSite Not Available
Impact Research Institute
Waco, Texas 76710
United StatesSite Not Available
Texas Digestive Disease Consultants - Bay Area Houston Endoscopy Center
Webster, Texas 77598
United StatesSite Not Available
Wasatch Peak Family Practice
Layton, Utah 84041
United StatesSite Not Available
Salt Lake City Research Center
Murray, Utah 84123
United StatesSite Not Available
Bon Secours Liver Institute of Richmond
Richmond, Virginia 23226
United StatesSite Not Available
National Clinical Research - Richmond
Richmond, Virginia 23294
United StatesSite Not Available
Virginia Commonwealth University School of Medicine
Richmond, Virginia 23298
United StatesSite Not Available
Liver Institute Northwest
Seattle, Washington 98105
United StatesSite Not Available

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