Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 2/2/2019 |
Start Date: | September 2015 |
End Date: | October 2022 |
Contact: | Carol Parish |
Email: | carol.parish@interceptpharma.com |
Phone: | +44 203 872 5027 |
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment
compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in
patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in
patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Inclusion Criteria:
1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than
6 months before Day 1 defined by presence of all 3 key histological features of NASH
according to NASH CRN criteria.
2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring
of fibrosis, or
Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by ≥1 of the
following risk factors:
- Obesity (BMI ≥30 kg/m2)
- Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria
- ALT >1.5× upper limit of normal (ULN).
3. For subjects with a historical biopsy, is either not taking or is on stable doses of
TZDs/glitazones or vitamin E for 6 months before Day 1.
4. Stable body weight.
Exclusion Criteria:
1. Model for End-stage Liver Disease (MELD) score >12
2. ALT ≥10× ULN
3. HbA1c >9.5%
4. Total bilirubin >1.5 mg/dL
5. Evidence of other known forms of known chronic liver disease such as alcoholic liver
disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease,
iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or
suspected hepatocellular carcinoma (HCC)
6. History of liver transplant, or current placement on a liver transplant list
7. Current or history of significant alcohol consumption
8. Prior or planned ileal resection, or prior or planned bariatric surgery
9. Histological presence of cirrhosis
10. History of biliary diversion
11. Known positivity for human immunodeficiency virus infection.
12. Acute cholecystitis or acute biliary obstruction.
13. BMI >45 kg/m2
We found this trial at
200
sites
Newport Beach, California 92660
Principal Investigator: Surinder S Saini, MD
Phone: 562-861-5690
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Ashwani Singal, MD
Phone: 205-975-4016
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Kathleen Corey, MD
Phone: 617-724-3836
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Michelle Lai, MD, MPH
Phone: 617-632-1068
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Samuel H Sigal, MD
Phone: 347-671-8216
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: A. Sidney Barritt, MD
Phone: 919-843-5936
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Andrew S deLemos, MD
Phone: 704-355-4875
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: K. Gautham Reddy, MD
Phone: 773-702-2788
University of Chicago One of the world's premier academic and research institutions, the University of...
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3300 Gallows Road
Falls Church, Virginia 22042
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Nila Rafiq, MD
Phone: 703-776-2056
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Moises Nevag Rubin, MD
Phone: 713-500-6654
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Brian B Borg, MD
Phone: 601-815-5180
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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4201 Belfort Road
Jacksonville, Florida 32216
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Maria Yataco, MD
Phone: 904-953-8030
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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Phone: 904-680-0871
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
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Phone: 310-423-4295
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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300 Community Drive
Manhasset, New York 11030
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: David E Bernstein, MD
Phone: 516-562-2060
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Minneapolis, Minnesota 55455
(612) 625-5000
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Phone: 612-624-5773
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
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Phone: 585-275-0803
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Seattle, Washington 98104
(206) 543-2100
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Phone: 206-543-0826
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
Weston, Florida 33331
866.293.7866
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Phone: 954-659-5888
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Albuquerque, New Mexico 87109
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Annapolis, Maryland 21401
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Arlington, Texas 76012
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Asheville, North Carolina 28801
Principal Investigator: Adam S Zivony, MD
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Athens, Georgia 30607
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Atlanta, Georgia 30308
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Phone: 404-881-1094
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Atlanta, Georgia 30309
Principal Investigator: Raymond A Rubin, MD
Phone: 404-605-2347
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1364 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Ryan Ford, MD
Phone: 404-712-1816
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, Georgia 30309
Principal Investigator: Michael R Galambos, MD
Phone: 678-686-5073
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1120 15th Street
Augusta, Georgia 30912
Augusta, Georgia 30912
(706) 721-0211
Principal Investigator: Sandeep Khurana, MBBS
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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13001 E. 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
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Phone: 303-724-8892
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Austin, Texas 78756
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Baltimore, Maryland 21202
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Baltimore, Maryland 21287
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
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Phone: 301-295-6127
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
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Phone: 617-638-6527
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Bowling Green, Kentucky 42101
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Bridgeport, Connecticut 06610
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Brockton, Massachusetts 02302
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Buffalo, New York 14215
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Burlington, Massachusetts 01805
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Burlington, Vermont 05405
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Catonsville, Maryland 21228
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1955 West Frye Road
Chandler, Arizona 85224
Chandler, Arizona 85224
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28207
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Charlottesville, Virginia 22903
(434) 924-0311
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Phone: 434-982-0709
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Chattanooga, Tennessee 37421
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Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
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Phone: 312-563-3919
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chula Vista, California 91911
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Chula Vista, California 91910
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45267
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Cleveland, Ohio 44194
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2500 Metrohealth Dr
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-7800
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Columbus, Georgia 31904
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Columbus, Ohio 43210
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Dallas, Texas 75203
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1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
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Dallas, Texas 75234
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Detroit, Michigan 48202
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Doral, Florida 33166
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Doylestown, Pennsylvania 18901
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2301 Erwin Rd
Durham, North Carolina 27710
Durham, North Carolina 27710
919-684-8111
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Phone: 919-684-4798
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Egg Harbor Township, New Jersey 08234
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El Cajon, California 92020
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Phone: 619-334-4735
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El Paso, Texas 79935
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Englewood, Colorado 80113
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Fayetteville, North Carolina 28304
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Fort Sam Houston, Texas 78234
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Fort Worth, Texas 76104
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Fresno, California 93701
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Phone: 559-499-6637
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7055 North Maple Avenue
Fresno, California 93720
Fresno, California 93720
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Gainesville, Florida 32610
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Greenville, South Carolina 29615
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Hamden, Connecticut 06518
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200 Medical Center Drive
Hazard, Kentucky 41701
Hazard, Kentucky 41701
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Houston, Texas 77021
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6550 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 790-3311
Principal Investigator: David W Victor, III, MD
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Idaho Falls, Idaho 83404
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Indianapolis, Indiana 46237
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550 University Boulevard
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
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Inverness, Florida 34452
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Jacksonville, Florida 32209
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
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Phone: 913-945-7830
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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425 Volker Boulevard
Kansas City, Missouri 64131
Kansas City, Missouri 64131
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Kansas City, Missouri 64128
Principal Investigator: Prashant Pandya, DO
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