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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03486912
Other study ID # MB130-069
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 12, 2018
Est. completion date September 14, 2021

Study information

Verified date October 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date September 14, 2021
Est. primary completion date October 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH and cirrhosis according to the NASH CRN classification, as assessed by the central reader - Must be taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period - Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the screening period. Vitamin E treatment (>=800 IU/day) must not have been initiated after the qualifying 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 [HCV], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, a-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible - 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 - Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy [EGD] performed within 12 months prior to the Screening Period has shown <= Grade 1 varices Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986036
Specified dose on specified days.
Other:
Placebo
Specified dose on specified days.

Locations

Country Name City State
Japan Fukushima Medical University Hospital Fukushima
Japan Local Institution - 0072 Kashihara Nara
Japan Kurume University Hospital Kurume Fukuoka
Japan Toranomon Hospital Minato Tokyo
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Local Institution - 0055 Yokohama Kanagawa
United States University of Michigan Ann Arbor Michigan
United States Texas Clinical Research Institute Arlington Texas
United States Local Institution Atlanta Georgia
United States Local Institution - 0066 Austin Texas
United States Local Institution - 0010 Baltimore Maryland
United States Boston Medical Center Boston Massachusetts
United States Local Institution - 0042 Bridgeport Connecticut
United States University at Buffalo Buffalo New York
United States University of Vermont Medical Center Burlington Vermont
United States Local Institution - 0067 Butner North Carolina
United States Local Institution - 0058 Catonsville Maryland
United States Local Institution - 0005 Chandler Arizona
United States Local Institution - 0064 Charlotte North Carolina
United States University of Virginia Health System Charlottesville Virginia
United States Local Institution Chattanooga Tennessee
United States Clinical Research Professionals Chesterfield Missouri
United States Northeast GI Research Division Concord North Carolina
United States Local Institution - 0079 Coral Gables Florida
United States Kindred Medical Institute for Clinical Trials Corona California
United States Local Institution - 0092 Coronado California
United States Top Medical Research Cutler Bay Florida
United States Local Institution - 0051 Dallas Texas
United States Local Institution - 0053 Dallas Texas
United States Texas Digestive Disease Consultants - Dallas Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States NECCR PrimaCare Research Fall River Massachusetts
United States Inova Fairfax Hospital Falls Church Virginia
United States Local Institution - 0084 Fort Worth Texas
United States Local Institution - 0046 Germantown Tennessee
United States Local Institution - 0041 Hermitage Tennessee
United States Clinical Research of Homestead Homestead Florida
United States Local Institution - 0002 Houston Texas
United States Local Institution - 0057 Houston Texas
United States Local Institution - 0063 Houston Texas
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Local Institution - 0031 Kansas City Missouri
United States Local Institution - 0038 La Jolla California
United States Local Institution - 0001 Lakewood Ranch Florida
United States Cedars-Sinai Medical Center Los Angeles California
United States GastroIntestinal Biosciences Los Angeles California
United States Local Institution - 0017 Los Angeles California
United States North Alabama Health Research, LLC Madison Alabama
United States Gastroenterology Associates, PC Manassas Virginia
United States Northwell Health Manhasset New York
United States Local Institution - 0108 Marietta Georgia
United States Tandem Clinical Research Marrero Louisiana
United States A+ Research Miami Florida
United States IMIC Research Miami Florida
United States Local Institution - 0003 Miami Florida
United States Catalina Research Institute Montclair California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Local Institution - 0026 New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Icahn School of Medicine at Mount Sinai New York New York
United States Local Institution - 0036 New York New York
United States Mount Sinai Hospital New York New York
United States Local Institution - 0069 Norfolk Virginia
United States Kaiser Permanente Oakland California
United States Sensible Healthcare Ocoee Florida
United States Local Institution - 0081 Orlando Florida
United States Diverse Research Solutions Oxnard California
United States Huntington Medical Research Institutes - HMRI Liver Center Pasadena California
United States Local Institution - 0020 Pasadena California
United States Local Institution - 0009 Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Local Institution - 0006 Phoenix Arizona
United States Local Institution - 0088 Phoenix Arizona
United States Local Institution - 0004 Pittsburgh Pennsylvania
United States Local Institution - 0073 Redwood City California
United States The Gastroenterology Group Reston Virginia
United States Local Institution - 0012 Rialto California
United States Bon Secours Liver Institute of Richmond Richmond Virginia
United States Local Institution - 0050 Richmond Virginia
United States Local Institution - 0077 Richmond Virginia
United States Saint Louis University Saint Louis Missouri
United States Local Institution - 0011 San Antonio Texas
United States Local Institution - 0028 San Antonio Texas
United States Local Institution - 0102 San Antonio Texas
United States Local Institution - 0089 San Clemente California
United States Local Institution San Diego California
United States Local Institution - 0014 San Diego California
United States Local Institution - 0068 San Francisco California
United States Local Institution Tampa Florida
United States Local Institution - 0090 Tucson Arizona
United States Local Institution Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Participants Who Achieve a = 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 An improvement in fibrosis is defined as a decrease of fibrosis by =1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by = 1-stage.
Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by =1 point. Worsening of fibrosis is defined as an increase of fibrosis by =1 point as determined by the NASH CRN Fibrosis Score.
From first dose to 48 weeks after first dose
Secondary The Percentage of Participants Who Achieve a = 1-Stage Improvement in Ishak Fibrosis Score at Week 48 An improvement in Ishak fibrosis is defined as a decrease of fibrosis by = 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis. From first dose to 48 weeks after first dose
Secondary The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 The percentage of participants who achieved a =1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 48 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a =2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). From first dose to 48 weeks after first dose
Secondary The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48 An improvement in fibrosis is defined as a decrease of = 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). From first dose to 48 weeks after first dose
Secondary The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48 An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy. From first dose to 48 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48 NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). From first dose to 48 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48 The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by = 2 points with contribution from > 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8. From first dose to 48 weeks after first dose
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