Liver Fibrosis Clinical Trial
— FALCON 1Official title:
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 Stage 3 Liver Fibrosis
Verified date | August 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Japan,
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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