A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Gastrointestinal, Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/23/2019 |
Start Date: | May 4, 2018 |
End Date: | April 5, 2021 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, |
Email: | Clinical.Trials@bms.com |
Phone: | please email: |
A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being
replaced by scar tissue).
Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being
replaced by scar tissue).
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Liver biopsy performed within 6 months prior to the Screening Visit; if not performed
within 6 months prior to the Screening Visit, a liver biopsy will be performed during
the Screening Period and at least 4 weeks prior to randomization (biopsy must be
consistent with NASH and cirrhosis according to the NASH CRN classification, as
assessed by the central reader)
- Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must
have been on stable dosing regimens for at least 3 months prior to the Screening Visit
- Participants taking vitamin E at doses ≥800 IU/day must have been on stable doses for
at least 6 months prior to the Screening Visit (Vitamin E treatment must not have been
initiated after the liver biopsy was performed)
Exclusion Criteria:
- Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus
infection, chronic hepatitis C virus infection, autoimmune hepatitis, drug-induced
hepatotoxicity, Wilson disease, alpha-1-antitrypsin deficiency, iron overload, and
hemochromatosis)
- Current or past history of hepatocellular carcinoma (HCC)
- Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding,
hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver
transplantation
Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
82
sites
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3300 Gallows Road
Falls Church, Virginia 22042
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-3592
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 832-355-8966
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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345 Saint Paul Place
Baltimore, Maryland 21202
Baltimore, Maryland 21202
Phone: 410-843-2075
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1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-645-6188
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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3409 Worth Street
Dallas, Texas 75231
Dallas, Texas 75231
Phone: 146993031244514
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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4401 Wornall Rd
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-2000
Phone: 816-932-3623
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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5901 West Olympic Boulevard
Los Angeles, California 90036
Los Angeles, California 90036
Phone: 13239540400249
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
(504) 588-5912
Phone: 504-988-5763
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
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70 Washington Square S
New York, New York 10012
New York, New York 10012
(212) 998-1212
Phone: 646-501-4926
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Phone: 212-241-0493
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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734 Fairmount Avenue
Pasadena, California 91105
Pasadena, California 91105
Phone: 626-397-5820
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111 S 11th St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-7979
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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1939 Roland Clarke Place
Reston, Virginia 20191
Reston, Virginia 20191
Phone: 571-281-1736
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45 Castro Street
San Francisco, California 94114
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-6525
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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