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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03486899
Other study ID # MB130-068
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 19, 2018
Est. completion date August 17, 2021

Study information

Verified date August 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 stage 3 liver fibrosis (severe fibrosis).


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date August 17, 2021
Est. primary completion date September 14, 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, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis 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 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 [HCV] infection, 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 Other protocol defined inclusion/exclusion criteria could 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 - 0056 Yokohama Kanagawa
United States University of Michigan Ann Arbor Michigan
United States Texas Clinical Research Institute Arlington Texas
United States Local Institution - 0066 Austin Texas
United States Local Institution - 0007 Baltimore Maryland
United States Boston Medical Center Boston Massachusetts
United States Bridgeport Hospital 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 - 0057 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 - 0063 Chesterfield Missouri
United States Local Institution - 0096 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 - 0052 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 Texas Digestive Disease Consultants - Southlake Fort Worth Texas
United States Local Institution - 0100 Gainesville Florida
United States Local Institution - 0047 Germantown Tennessee
United States Local Institution - 0041 Hermitage Tennessee
United States Clinical Research of Homestead Homestead Florida
United States Local Institution - 0004 Houston Texas
United States Local Institution - 0059 Houston Texas
United States Local Institution - 0062 Houston Texas
United States Local Institution - 0082 Jacksonville Florida
United States Saint Lukes Hospital of Kansas City Kansas City Missouri
United States University of California San Diego La Jolla California
United States Local Institution - 0003 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 Local Institution - 0087 Madison Alabama
United States Gastroenterology Associates, PC Manassas Virginia
United States Local Institution - 0078 Manhasset New York
United States Local Institution - 0105 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 - 0002 Miami Florida
United States Catalina Research Institute Montclair California
United States Vanderbilt University Medical Center Nashville Tennessee
United States Local Institution - 0027 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 - 0038 New York New York
United States Local Institution - 0083 New York New York
United States Local Institution - 0069 Norfolk Virginia
United States Local Institution - 0008 Oakland California
United States Sensible Healthcare Ocoee Florida
United States Local Institution - 0081 Orlando Florida
United States Local Institution - 0044 Oxnard California
United States Huntington Medical Research Institutes - HMRI Liver Center Pasadena California
United States Local Institution - 0019 Pasadena California
United States Local Institution - 0009 Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Local Institution - 0001 Phoenix Arizona
United States Local Institution - 0088 Phoenix Arizona
United States Local Institution - 0006 Pittsburgh Pennsylvania
United States Local Institution - 0074 Redwood City California
United States The Gastroenterology Group Reston Virginia
United States Local Institution - 0013 Rialto California
United States Bon Secours Liver Institute of Richmond Richmond Virginia
United States Local Institution - 0049 Richmond Virginia
United States Local Institution - 0077 Richmond Virginia
United States Saint Louis University Saint Louis Missouri
United States Local Institution - 0012 San Antonio Texas
United States Local Institution - 0029 San Antonio Texas
United States Local Institution - 0101 San Antonio Texas
United States Local Institution - 0089 San Clemente California
United States Medical Associates Research Group San Diego California
United States Local Institution - 0068 San Francisco California
United States Tampa General Hospital Tampa Florida
United States The Institute for Liver Health - Tucson Tucson Arizona
United States MedStar Georgetown University Hospital 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 With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 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 24 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). 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. 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 24 weeks after first dose
Secondary The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24 An improvement in fibrosis is defined as a decrease of = 1-stage in the NASH CRN Fibrosis Score at week 24 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 24 weeks after first dose
Secondary The Percentage of Participants Who Achieve a = 1-Stage Improvement in Ishak Fibrosis Score at Week 24 An improvement in Ishak fibrosis is defined as a decrease of fibrosis by = 1-stage in the Ishak fibrosis score at week 24 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 24 weeks after first dose
Secondary The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24 An improvement in CPA is defined as any decrease in CPA at week 24 in liver biopsy. From first dose to 24 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24 The percentage of participants with NASH resolution without worsening of fibrosis at week 24 in liver biopsy. NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1. Worsening of fibrosis is defined as an increase of fibrosis by = 1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score.
Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). 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 24 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24 NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 24 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade <2). From first dose to 24 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24 The percentage of participants with NASH improvement without worsening of fibrosis at week 24 in liver biopsy. NASH improvement defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by =2 points with contribution from >1 NAS component. Worsening of fibrosis is defined as an increase of =1-point in the NASH Clinical Research Network (CRN) Fibrosis Score. 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 24 weeks after first dose
Secondary The Percentage of Participants Who Achieve a = 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24 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 24 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by = 1-stage. 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 24 weeks after first dose
Secondary The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24 The percentage of participants with NASH improvement at week 24 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 24 weeks after first dose
Secondary The Percentage of Participants With Progression to Cirrhosis at Week 24 Progression to cirrhosis is defined by the nonalcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Stage 4 at Week 24 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 24 weeks after first dose
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