Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:August 30, 2017
End Date:July 2021
Contact:Roger Davies
Email:roger.davies@interceptpharma.com
Phone:1-619-541-7249

Use our guide to learn which trials are right for you!

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747)
can lead to histological improvement in fibrosis with no worsening of NASH in adults with
compensated cirrhosis due to NASH.


Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the
NASH CRN scoring system determined by central reading

Key exclusion criteria:

1. Current or past history of hepatic decompensation such as clinically significant
ascites, hepatic encephalopathy (HE), or variceal bleeding

2. Current or past history of CP score ≥7 points

3. Model for End-stage Liver Disease (MELD) score > 12

4. ALT ≥ 5 X ULN

5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method

6. Hemoglobin A1c ≥ 9.5 %

7. Evidence of other known forms of 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)

8. History of liver transplant, or current placement on a liver transplant list
We found this trial at
176
sites
Saint Paul, Minnesota 55114
Principal Investigator: Donald Zogg, MD
Phone: 612-870-5597
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Kathleen Corey, MD
Phone: 617-724-3836
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Michelle Lai, MD
Phone: 617-632-1129
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Samuel Sigal, MD
Phone: 718-920-4354
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Thomas Amankonah, MD
Phone: 601-815-5180
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jonathan Dranoff, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
Principal Investigator: Shahriar Sedghi, MD
Phone: 478-464-2600
?
mi
from
Macon, GA
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: K. Reddy, MD
Phone: 215-349-8563
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Jonathan Huang, DO
Phone: 585-276-3042
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Douglas Denham, DO, CPI
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Hari Conjeevaram, MD
Phone: 734-764-4048
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington, Texas 76012
Principal Investigator: Reem Ghalib, MD
Phone: 817-471-1070
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
Principal Investigator: Adam Zivony, MD
Phone: 828-254-0881
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Jeffrey Williams, MD
Phone: 706-400-4262
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30308
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30322
Principal Investigator: Ryan Ford, MD
Phone: 404-712-1737
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Amanda Wieland, MD
Phone: 303-724-1871
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
Principal Investigator: Isaac Bassan, MD
Phone: 305-759-1881
?
mi
from
Aventura, FL
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: Paul Thuluvath, MD
Phone: 410-843-2069
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21201
Principal Investigator: Jennifer Husson, MD, MPH
Phone: 410-706-2564
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beavercreek, Ohio 45440
Principal Investigator: Rupa Fritz, MD
Phone: 937-320-5050
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Dawn Torres, MD
Phone: 301-319-8713
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18017
Principal Investigator: Adam Peyton, DO
Phone: 610-433-4100
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35294
Principal Investigator: Omar Massoud, MD
Phone: 205-934-7332
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bronx, New York 10459
Principal Investigator: David Bernard, MD
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Buffalo, New York 14203
Principal Investigator: Andrew Talal, MD
Phone: 716-878-3320
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burlington, Massachusetts 01805
Principal Investigator: Frederic Gordon, MD
Phone: 781-744-3367
?
mi
from
Burlington, MA
Click here to add this to my saved trials
Burlington, Vermont 05405
Principal Investigator: Steven Lidofsky, MD, PhD
Phone: 802-656-9957
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Canoga Park, California 91303
Principal Investigator: Hessam Aazami, MD
Phone: 818-999-4673
?
mi
from
Canoga Park, CA
Click here to add this to my saved trials
1955 West Frye Road
Chandler, Arizona 85224
Principal Investigator: Anita Kohli, MD
Phone: 480-767-4541
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
850 North Kolb Road
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Principal Investigator: A. Barritt, IV, MD
Phone: 919-843-5732
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
109 Bee Street
Charleston, South Carolina 29401
Principal Investigator: Wing-Kin Syn, MD
Phone: 843-789-7816
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29425
Principal Investigator: Don Rockey, MD
Phone: 843-876-8439
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
Principal Investigator: Jason Wilson, MD
Phone: 704-602-6564
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60611
Principal Investigator: Mary Rinella, MD
Phone: 312-694-0326
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Sujit Janardhan, MD
Phone: 312-942-3354
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
Principal Investigator: Cynthia Schaeffer, MD
Phone: 619-501-0371
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
Principal Investigator: Ravi Ravinuthala, MD
Phone: 513-587-0410
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45267
Principal Investigator: Kenneth Sherman, MD, PhD
Phone: 513-584-5245
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
Principal Investigator: Bhaktasharan Patel, MD
Phone: 719-362-2270
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Na Li, MD, PhD
Phone: 614-366-6199
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Coral Gables, Florida 33134
Principal Investigator: Jorge Beato, MD
Phone: 786-717-7515
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Cutler Bay, Florida 33189
Principal Investigator: Jose Ruiz, MD
Phone: 305-971-6883
?
mi
from
Cutler Bay, FL
Click here to add this to my saved trials
Dallas, Texas 75234
Principal Investigator: Abdullah Mubarak, MD
Phone: 469-317-7703
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
Principal Investigator: James Trotter, MD
Phone: 817-310-4480
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75203
Principal Investigator: Parvez Mantry, MD
Phone: 214-947-1280
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Carol Murakami, MD
Phone: 214-645-6188
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Doral, Florida 33166
Principal Investigator: Adolpho Cueli, MD
Phone: 305-552-7660
?
mi
from
Doral, FL
Click here to add this to my saved trials
Dothan, Alabama 36305
Principal Investigator: William McLaughlin, MD
Phone: 334-836-3341
?
mi
from
Dothan, AL
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Manal Abdelmalek, MD
Phone: 919-684-0816
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Englewood, Colorado 80113
Principal Investigator: Marcelo Kugelmas, MD
Phone: 303-406-4139
?
mi
from
Englewood, CO
Click here to add this to my saved trials
1811 Bethlehem Pike
Flourtown, Pennsylvania 19031
Principal Investigator: Victor Araya, MD
Phone: 215-402-0800
?
mi
from
Flourtown, PA
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
Principal Investigator: Angelo Paredes, MD
Phone: 210-916-2746
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
1400 8th Avenue
Fort Worth, Texas 76104
Principal Investigator: Stevan Gonzalez, MD
Phone: 817-922-2572
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fort Worth, Texas 76104
Principal Investigator: Apurva Modi, MD
Phone: 817-310-4478
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California
Principal Investigator: Marina Roytman, MD
Phone: 559-499-6637
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Zaid Younes, MD
Phone: 301-309-6030
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Gulfport, Mississippi 39501
Principal Investigator: Navin Barot, MD
Phone: 512-717-8610
?
mi
from
Gulfport, MS
Click here to add this to my saved trials
Haines City, Florida 33844
Principal Investigator: Raphael Lopez, MD
?
mi
from
Haines City, FL
Click here to add this to my saved trials
Hermitage, Tennessee
Principal Investigator: Kevin Finnegan, MD
Phone: 615-499-4740
?
mi
from
Hermitage, TN
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
Principal Investigator: Karen Krok, MD
Phone: 717-531-5226
?
mi
from
Hershey, PA
Click here to add this to my saved trials
6620 Main Street
Houston, Texas 77030
Principal Investigator: John Vierling, MD
Phone: 713-798-5382
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Maya Balakrishman, MD, MPH
Phone: 713-798-7542
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Victor Ankoma-Sey, MD
Phone: 713-799-2667
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Moises Nevah Rubin, MD
Phone: 713-500-6456
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77036
Principal Investigator: Alan Glombicki, MD
Phone: 281-324-0575
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: David Victor, III, MD
Phone: 713-441-6316
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77062
Principal Investigator: Joe Puzar, MD
Phone: 281-282-0808
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77089
Principal Investigator: Munir Loya, MD
Phone: 832-847-1727
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
Principal Investigator: Robert Reindollar, MD
Phone: 704-801-5203
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
Huntersville, North Carolina 28078
Principal Investigator: Robert Reindollar, MD
Phone: 704-355-4875
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
Idaho Falls, Idaho 83404
Principal Investigator: Larry Evans, DO
Phone: 208-428-5246
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
?
mi
from
Inverness, FL
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Huy Tran
Phone: 319-353-4575
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39216
Principal Investigator: Brian Borg, MD
Phone: 769-251-5674
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jackson, Tennessee 38305
Principal Investigator: Bob Souder, MD
Phone: 731-431-5027
?
mi
from
Jackson, TN
Click here to add this to my saved trials
4555 Emerson Street
Jacksonville, Florida 32207
Principal Investigator: Miguel Malespin, MD
Phone: 904-633-0070
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jacksonville, Florida 32256
Principal Investigator: Linda DiTeodoro, MD
Phone: 904-680-0871
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Maria Yataco, MD
Phone: 904-953-8503
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johnson City, Tennessee 37604
Principal Investigator: Chakradhar Reddy, MD
Phone: 423-434-3701
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
Kansas City, Kansas 64128
Principal Investigator: Prashant Pandya, DO
Phone: 816-861-4700
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Winston Dunn, MD
Phone: 913-588-3708
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
Principal Investigator: Bradley Freilich, MD
Phone: 816-759-5274
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kingswood, New South Wales
Principal Investigator: Martin Weltman, MBBS, PhD
Phone: +61 2 4734 2319
?
mi
from
Kingswood,
Click here to add this to my saved trials
Kissimmee, Florida 34759
Principal Investigator: Syed Mumtaz, MD
Phone: 407-932-1977
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
La Jolla, California
Principal Investigator: Paul Pockros, MD
Phone: 858-336-4314
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
La Jolla, California 92037
Principal Investigator: Rohit Loomba, MD, MHSc.
Phone: 858-246-0006
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
La Mesa, California 91942
Principal Investigator: J. Overcash, MD
Phone: 619-567-1550
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
Lakewood Ranch, Florida 34211
Principal Investigator: Guy Neff, MD
Phone: 941-727-7772
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89106
Principal Investigator: Vishweshwar Ranga, MD
Phone: 702-909-0217
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89109
Principal Investigator: Heidi Kabler, MD
Phone: 702-410-2970
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Principal Investigator: Alonzo Williams, MD
Phone: 501-687-9300
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Live Oak, Texas 78233
Principal Investigator: Stephen Harrison, MD
Phone: 210-982-0320
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Liyan Yuan, MD
Phone: 323-442-8152
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90048
Principal Investigator: Vinay Sundaram, MD
Phone: 310-423-4295
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90073
Principal Investigator: Joseph Pisegna, MD
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
323 East Chestnut Street
Louisville, Kentucky 40202
Principal Investigator: Matthew Cave, MD
Phone: 502-852-3383
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53705
Principal Investigator: Adnan Said, MD
Phone: 608-262-5404
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
Principal Investigator: Aasim Sheikh, MD
Phone: 678-819-4221
?
mi
from
Marietta, GA
Click here to add this to my saved trials