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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004566-26 | EudraCT Number | ||
| 1001 | Registry Identifier | Registro Nacional Estudios Clinicos (RNEC) |
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This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.
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The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Participants from Part 1 will continue into Part 2 and additional participants will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. |
|
| Cenicriviroc 150 mg | Experimental | Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12 | Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | Month 12 |
| Time to First Occurrence of Adjudicated Events in the Full Study Cohort | Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality. | From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerardo Rodriguez | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Internal Medicine | Birmingham | Alabama | 35243 | United States | ||
| Cullman Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37061109 | Derived | Anstee QM, Neuschwander-Tetri BA, Wai-Sun Wong V, Abdelmalek MF, Rodriguez-Araujo G, Landgren H, Park GS, Bedossa P, Alkhouri N, Tacke F, Sanyal AJ. Cenicriviroc Lacked Efficacy to Treat Liver Fibrosis in Nonalcoholic Steatohepatitis: AURORA Phase III Randomized Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):124-134.e1. doi: 10.1016/j.cgh.2023.04.003. Epub 2023 Apr 13. |
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1778 participants were randomized into the study, of which 1293 participated in Part 1 of the study. The study was terminated early, and Part 2 did not enroll the planned number of participants. Therefore, the Part 1 and Part 2 data were combined and reported as the Full Study Cohort for reporting of the Part 2 efficacy endpoints and the safety endpoints.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. |
| FG001 | Cenicriviroc 150 mg | Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2019 | Dec 22, 2021 |
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| Cenicriviroc | Drug | Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months. |
|
|
| Month 12 |
| Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | Month 12 |
| Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | Month 12 |
| Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | Month 12 |
| Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | Month 12 |
| Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | Month 12 |
| Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | Month 12 |
| Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | Month 60 |
| Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | Month 60 |
| Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | Month 60 |
| Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis. | Month 60 |
| Cullman |
| Alabama |
| 35055 |
| United States |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States |
| Objective GI D/B/A North Alabama GI Research Center | Madison | Alabama | 35758 | United States |
| The Institute for Liver Health | Chandler | Arizona | 85224 | United States |
| Adobe Gastroenterology Research, LLC | Tucson | Arizona | 85712 | United States |
| Del Sol Research Management, LLC | Tucson | Arizona | 85712 | United States |
| Del Sol Research Management LLC | Tucson | Arizona | 85745 | United States |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | United States |
| Franco Felizarta MD | Bakersfield | California | 93301 | United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| GW Research | Chula Vista | California | 91910 | United States |
| eStudySite | Chula Vista | California | 91911 | United States |
| Southern California Research Center | Coronado | California | 92118 | United States |
| Citrus Valley Gastroenterology | Covina | California | 91722 | United States |
| TriWest Research Associates | El Cajon | California | 92020 | United States |
| University of San Francisco, Fresno Medical Education Program | Fresno | California | 93701 | United States |
| Fresno Clinical Research Center (FCRC) | Fresno | California | 93720 | United States |
| National Research Institute | Huntington Park | California | 90255 | United States |
| University of California San Diego | La Jolla | California | 92037 | United States |
| eStudySite | La Mesa | California | 91942 | United States |
| Om Research | Lancaster | California | 93534 | United States |
| Southern California Kaiser Permanente, Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| GastroIntestinal Biosciences | Los Angeles | California | 90036 | United States |
| Global Research Institute | Los Angeles | California | 90036 | United States |
| Ruane Medical and Liver Health Institute | Los Angeles | California | 90036 | United States |
| Cedars-Sinai Medical Group | Los Angeles | California | 90048 | United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| Palmtree Clinical Research Inc. | Palm Springs | California | 92262 | United States |
| National Research Institute | Panorama City | California | 91402 | United States |
| Pasadena Liver Center | Pasadena | California | 91105 | United States |
| Alliance Clinical Research LLC | Poway | California | 92064 | United States |
| Stanford School of Medicine, Center for Clinical Sciences Research | Redwood City | California | 94063 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377-4697 | United States |
| Precision Research Institute | San Diego | California | 92114 | United States |
| Southern California Permanente Medical Group | San Diego | California | 92154 | United States |
| UCSF School of Medicine | San Francisco | California | 94143-0538 | United States |
| Upland Clinical Research | Upland | California | 91786 | United States |
| Island View GI | Ventura | California | 93003 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | United States |
| Western States Clinical Research, Inc. | Wheat Ridge | Colorado | 80033 | United States |
| Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | 06606 | United States |
| Yale University - New Haven | New Haven | Connecticut | 06511 | United States |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | United States |
| Gastro Florida | Clearwater | Florida | 33761 | United States |
| Hi Tech and Global Research, LLC | Coral Gables | Florida | 33134 | United States |
| Top Medical Research, Inc | Cutler Bay | Florida | 33189 | United States |
| ICR Sites | Doral | Florida | 33166 | United States |
| Qway Research, LLC | Hialeah | Florida | 33010 | United States |
| Gastroenterology Associates - Crystal River | Inverness | Florida | 34452 | United States |
| Mayo Clinic College of Medicine | Jacksonville | Florida | 32224 | United States |
| Meridien Research | Lakeland | Florida | 33803 | United States |
| Florida Digestive Health Specialists | Lakewood Rch | Florida | 34211 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States |
| Bruce W. Carter Department of Veterans Affairs Medical Center | Miami | Florida | 33125 | United States |
| Optimus U Corporation | Miami | Florida | 33125 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157 | United States |
| Genoma Research Group Inc. | Miami | Florida | 33165 | United States |
| Medical Professional Clinical Research Center, INC | Miami | Florida | 33165 | United States |
| ProLive Medical Research | Miami | Florida | 33175 | United States |
| San Marcus Research Clinic | Miami Lakes | Florida | 33014 | United States |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | United States |
| Bioclinical Research Alliance | Orlando | Florida | 32806 | United States |
| Omega Research Maitland, LLC | Orlando | Florida | 32810 | United States |
| IMIC, Inc | Palmetto Bay | Florida | 33157 | United States |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | United States |
| Gastroenterology Associates of Pensacola | Pensacola | Florida | 32503 | United States |
| Advanced Medical Research | Port Orange | Florida | 32127 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Guardian Angel Research Center | Tampa | Florida | 33614 | United States |
| Bioclinica Research | The Villages | Florida | 32162 | United States |
| Florida Medical Clinic | Zephyrhills | Florida | 33542 | United States |
| Summit Clinical Research, LLC | Athens | Georgia | 30607 | United States |
| Digestive Healthcare of Georgia - Atlanta | Atlanta | Georgia | 30309 | United States |
| Piedmont Healthcare INC. | Atlanta | Georgia | 30309 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| GI Specialists of Georgia - Marietta Office | Marietta | Georgia | 30060 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Investigators Research Group, LLC | Brownsburg | Indiana | 46112 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Aquiant Research | New Albany | Indiana | 47150 | United States |
| Digestive Research Alliance of Michiana | South Bend | Indiana | 46635 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kansas Medical Clinic-Gastroenterology | Topeka | Kansas | 66606 | United States |
| Delta Research Partners, LLC | Bastrop | Louisiana | 71220 | United States |
| Avant Research Associates LLC | Crowley | Louisiana | 70526 | United States |
| C-1 Headlands, Inc. | Lake Charles | Louisiana | 70601 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Nola Research Works, LLC | New Orleans | Louisiana | 70125 | United States |
| Louisiana Research Center | Shreveport | Louisiana | 71105 | United States |
| Clinical Trials of America LLC | West Monroe | Louisiana | 71291 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Digestive Disease Associates | Catonsville | Maryland | 21228 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | 21061 | United States |
| Victory Clinical Research | Greenbelt | Maryland | 20770 | United States |
| Meritus Center for Clinical Research | Hagerstown | Maryland | 21742 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| Umass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Minnesota Gastroenterology, P.A. | Maplewood | Minnesota | 55117 | United States |
| National Diabetes and Obesity Research Institute | Biloxi | Mississippi | 39532 | United States |
| GastroIntestinal Associates | Flowood | Mississippi | 39232 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Machuca Family Medicine | Las Vegas | Nevada | 89104 | United States |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 89106 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Excel Clinical Research | Las Vegas | Nevada | 89109 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Amici Clinical Research | Raritan | New Jersey | 08869 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| NYU Langone Health - Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Tandem Clinical Research | New York | New York | 10033 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Investigational Drug Service, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Northeast GI Research Division | Concord | North Carolina | 28027 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | United States |
| Carolina Research | Greenville | North Carolina | 27834 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| The Ohio University - Gastroenterology, Hepatology | Columbus | Ohio | 43210 | United States |
| Digestive Disease Specialist, Inc. | Oklahoma City | Oklahoma | 73112 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| Eastern Pennsylvania Gastroenterology and Liver Specialist | Bethlehem | Pennsylvania | 18017 | United States |
| UPMC -Center for Liver Diseases | Pittsburgh | Pennsylvania | 15213 | United States |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| Care Access Research, Pottsville | Pottsville | Pennsylvania | 17901 | United States |
| Digestive Disease Associates, LTD | Wyomissing | Pennsylvania | 19610 | United States |
| Partners in Clinical Research | Cumberland | Rhode Island | 02864 | United States |
| University Medical Group | North Providence | Rhode Island | 02908 | United States |
| Care Access Research-Warwick | Warwick | Rhode Island | 02886 | United States |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | United States |
| Mount Vernon Clinical Research | Chattanooga | Tennessee | 37421 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Digestive Health Research | Hermitage | Tennessee | 37076 | United States |
| East Tennessee Research Institute | Johnson City | Tennessee | 37604 | United States |
| Digestive Health Research | Lebanon | Tennessee | 37090 | United States |
| UT-Memphis, Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232-1610 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Liver Center of Texas | Dallas | Texas | 75234 | United States |
| Synexus | Dallas | Texas | 75234 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Baylor Scott & White All Saints Medical Center - Ft. Worth | Fort Worth | Texas | 76104 | United States |
| Texas Digestive Disease Consultants - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Digestive Health Associates of Texas-Rockwall | Garland | Texas | 75044 | United States |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | United States |
| Pioneer Research Solutions, Inc. | Houston | Texas | 77009 | United States |
| Liver Associates of Texas | Houston | Texas | 77030-3002 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center (MEDVAMC) | Houston | Texas | 77030 | United States |
| St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | United States |
| Centex Studies | Houston | Texas | 77058 | United States |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | United States |
| Amir Ali Hassan, MD, PA | Houston | Texas | 77089 | United States |
| Centex Studies, Inc. | McAllen | Texas | 78504 | United States |
| LinQ Research, LLC | Pearland | Texas | 77584 | United States |
| Quality Research Inc. | San Antonio | Texas | 78209 | United States |
| American Research Corporation | San Antonio | Texas | 78215 | United States |
| Clinical Trials of Texas Inc | San Antonio | Texas | 78229 | United States |
| Diabetes & Glandular Disease Clinic, P.A. (DGD) | San Antonio | Texas | 78229 | United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| Southern Star Research Institute, LLC SAGACT PLLC. | San Antonio | Texas | 78229 | United States |
| Anson Medicine | San Antonio | Texas | 78260 | United States |
| Mount Olympus Medical Research, LLC | Sugar Land | Texas | 77479 | United States |
| Texas Digestive Disease Consultants | Webster | Texas | 77598 | United States |
| Physician's Research Options, LLC | Draper | Utah | 84020 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Advanced Clinical Research - Center for Digestive Health | Riverton | Utah | 84065 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States |
| VCU Medical Center | Richmond | Virginia | 23298 | United States |
| Gastroenterology Consultants of Southwest Virginia Research | Roanoke | Virginia | 24014 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Marshall University Joan C. Edwards School of Medicine | Huntington | West Virginia | 25701 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Saint George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Flinders Medical Center | Adelaide | South Australia | 5042 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Universitatsklinik far Innere Medizin | Graz | Styria | 8036 | Austria |
| Universitatsklinik far Innere Medizin II | Innsbruck | Tyrol | 6020 | Austria |
| Klinikum Wels-Grieskirchen | Wels | Upper Austria | 4600 | Austria |
| Universitair Ziekenhuis Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Hôpital Erasme | Brussels | Brussels Capital | 1070 | Belgium |
| Algemeen Ziekenhuis Maria Middelares | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Centre Hospitalier Chretien CHC | Liège | 4000 | Belgium |
| Hospital das Clínicas da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Faculdade de Medicina de São José do Rio Preto Hospital de Base | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Hospital Universitário Clementino Fraga Filho | Rio de Janeiro | 21941-913 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
| University of Calgary Liver Unit | Calgary | Alberta | T2N 4Z6 | Canada |
| Bailey Health Clinic | Edmonton | Alberta | T5H 4B9 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| William Osler Health Centre, Brampton Memorial Hospital Campus | Brampton | Ontario | L6R 3J7 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Ecogene-21 | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Centro de Investigaciones Clínicas Viña del Mar | Viña del Mar | Valparaiso | 2540488 | Chile |
| CHU de Strasbourg | Strasbourg | Alsace | 67091 | France |
| CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique | Pessac | Aquitaine | 33604 | France |
| Centre Hospitalier Universitaire Estaing | Clermont-Ferrand | Aubergne | 63003 | France |
| Centre Hospitalier Universitaire Grenoble | Grenoble | Auvergne-Rhône-Alpes | 38700 | France |
| Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou | Rennes | Brittany Region | 35033 | France |
| Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz | Besançon | Franche-Comte | 25030 | France |
| CHU de Montpellier | Montpellier | Languedoc-Roussillon | 34295 | France |
| Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle | Rouen | Normandy | 76000 | France |
| Center Hospitalier Universitaire d'Angers | Angers | Pays de la Loire Region | 49000 | France |
| Hapital Sud Service d'Hepato- Gastroentarologie | Amiens | Picardie | 80054 | France |
| Centre Hospitalier Universitaire de Nice Hôpital l'Archet | Nice | Provence-Alpes-Côte d'Azur Region | 06202 | France |
| Hopital Avicenne | Bobigny | 93000 | France |
| Departement d'Hacpatologie | Clichy | Île-de-France Region | 92110 | France |
| Hôpital Saint Antoine | Paris | Île-de-France Region | 75571 | France |
| Synexus Clinical Research GmbH, Prüfzentrum Frankfurt | Frankfurt am Main | Hesse | 60313 | Germany |
| Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH | Marburg | Hesse | 35043 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Gastroenterologische Gemeinschaftspraxis | Herne | Nordhein-Westfalen | 44623 | Germany |
| Uniklinik RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Uniklinik Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Saarland | 66427 | Germany |
| Universitätsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Praxis Driesener Strasse | Berlin | 10439 | Germany |
| Synexus Clinical Research GmbH, Prüfzentrum Berlin | Berlin | 12627 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Thomopoulos Gastroenterology Dept. | Patra | Peloponnese | 26504 | Greece |
| Hippokratio Hospital | Thessaloniki | 54642 | Greece |
| Prince of Wales Hospital | Shatin | New Territories | 00852 | Hong Kong |
| Alice Ho Miu Ling Nethersole Hospital | Shatin | New Territories | Hong Kong |
| Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | Somogy County | 7400-7400 | Hungary |
| SYNEXUS Magyarország Kft. - Budapest DRS | Budapest | 1036 | Hungary |
| Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft | Debrecen | 4025 | Hungary |
| EMMS MC | Nazareth | Jerusalem | 91031 | Israel |
| Rambam Health Care Campus - Rambam Medical Center | Haifa | 31999 | Israel |
| Carmel Medical Center | Haifa | 34362 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases | Jerusalem | 91120 | Israel |
| Galilee Medical Center | Nahariya | 22100 | Israel |
| Rabin Medical Center Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Milano | 20162 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia | Florence | 50134 | Italy |
| ASST Santi Paolo e Carlo | Milan | 20142 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo | 90127 | Italy |
| Fondazione Policlinico Tor Vergata | Roma | 00133 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| Pauls Stradins Clinical University Hospital | Riga | LV-1002-1002 | Latvia |
| Consultorio Médico Dr. Alma Laura Ladron de Guevara | Mexico City | Mexico City | 06700 | Mexico |
| JM Research - Cuernavaca | Cuernavaca | Morelos | 62290 | Mexico |
| Investigaciones Medicas Cisneros | Monterrey | Nuevo León | 64000 | Mexico |
| Consultorio Dra. Maria Sarai Gonzalez Huezo | Metepec | 52140 | Mexico |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Middlemore Clinical Trials | Papatoetoe | Auckland | 2025 | New Zealand |
| Oslo Universitetssykehus-Ullevål | Oslo | 0450 | Norway |
| Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska | Wroclaw | Lower Silesian Voivodeship | 51-162 | Poland |
| EMC Instytut Medyczny | Wroclaw | Lower Silesian Voivodeship | 54-144 | Poland |
| Szpital Specjalistyczny Nr 1 w Bytomiu | Bytom | Silesian Voivodeship | 41-902 | Poland |
| ID Clinic Arkadiusz Pisula | Mysłowice | Silesian Voivodeship | 41400-400 | Poland |
| Synexus Polska Sp z o o Oddzial w Poznaniu | Poznan | Wielkopolska | 60 702-702 | Poland |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | Wroclaw | 50-381 | Poland |
| Synexus Polska Sp. Z o.o. Oddzial w Czestochowie | Częstochowa | 0 42-202 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | 80-382 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni ul. | Gdynia | 81-537 | Poland |
| Synexus SCM Sp. z o.o. Oddzial | Katowice | 40-040 | Poland |
| Synexus Polska Sp. z o.o. Oddział w Warszawie | Warsaw | 01-192 | Poland |
| Synexus Polska Sp. z o.o. Oddział w Łodzi | Lodz | Łódź Voivodeship | 90-127 | Poland |
| Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi | Lódz | Łódź Voivodeship | 91-347 | Poland |
| Presa-Ramos | Vila Real | Lordelo | 5000-508 | Portugal |
| Unidade Local de Saúde do Alto Minho | Viana do Castelo | 4904-858 | Portugal |
| Clinical Research Puerto Rico | San Juan | PR | 00909-1711 | Puerto Rico |
| Fundacion de Investigacion De Diego | San Juan | 00927 | Puerto Rico |
| Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor | Cluj-Napoca | Cluj | 400162 | Romania |
| Clinic Professor Gorbakova | Krasnogorsk | Moscow | 143405 | Russia |
| Sklifosovsky Scientific Research Institution of Emergency Care | Moscow | 129090 | Russia |
| Moscow Regional Research and Clinical Institute M.F. Vladimirsky | Moscow | 129110 | Russia |
| National University Hospital | Singapore | 119082 | Singapore |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Torrecardenas | Almería | 4009 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Ramón Y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Nuestra Senora de Valme | Seville | 41014 | Spain |
| Consorci Hospital General Universitari de València | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Kantonsspital St.Gallen Klinik für | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Universitaetsspital Bern Inselspital | Bern | 3010 | Switzerland |
| Chia-Yi Christian Hospital | Chiayi City | Chiayi | 60002 | Taiwan |
| China Medical University Hospital | Taichung | Taichung City | 404 | Taiwan |
| Chang Gung Medical Foundation-LinKou Branch | Taoyuan | 333 | Taiwan |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | England | B15 2TH | United Kingdom |
| Hull and East Yorkshire Hospitals NHS Trust | Hull | England | HU3 2JZ | United Kingdom |
| Royal Free London NHS Foundation Trust | London | England | NW3 2QG | United Kingdom |
| Kings College Hospital NHS Foundation Trust | London | England | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | London | England | SW10 9NH | United Kingdom |
| Luton and Dunstable Hospital NHS Foundation Trust | Luton | England | LU4 0DZ | United Kingdom |
| Newcastle Upon the Tyne Hospitals | Newcastle | England | NE2 7DN | United Kingdom |
| Nottingham Digestive Diseases Biomedical Research Unit | Nottingham | England | NG7 2UH | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | England | PL6 8DH | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | England | ST4 6QG | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS97TF | United Kingdom |
| Synexus Hexham Clinical Research Centre | Hexham | NE46 1QJ | United Kingdom |
| Synexus Lancashire Clinical Research Centre | Lancaster | PR7 7NA | United Kingdom |
| Barts Health NHS Trust The Royal London Hospital | London | E1 1BB | United Kingdom |
| University Hospital of South Manchester NHS Foundation Trust | Manchester | M23 9LT | United Kingdom |
| Full Study Cohort: Received Study Drug |
|
| Participated in Part 1 |
|
| Part 1: Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent-to-Treat (mITT) Population for the Full Study Cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. |
| BG001 | Cenicriviroc 150 mg | Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12 | Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Primary | Time to First Occurrence of Adjudicated Events in the Full Study Cohort | Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality. | mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. | Posted | Median | 95% Confidence Interval | days | From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months) |
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| Secondary | Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12 | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | percentage of participants | Month 12 |
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| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug for Parts 1 and 2 of the study combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses. | Posted | Number | percentage of participants | Month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | No data was collected as the study was terminated and no participants reached the Month 60 timepoint. | Posted | Month 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis. | No data was collected as the study was terminated and no participants reached the Month 60 timepoint. | Posted | Month 60 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage. | No data was collected as the study was terminated and no participants reached the Month 60 timepoint. | Posted | Month 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort | Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis. | No data was collected as the study was terminated and no participants reached the Month 60 timepoint. | Posted | Month 60 |
|
|
From first dose through 30 days after the last dose of study drug (Up to approximately 42 months)
All-cause Mortality: All enrolled participants. Serious Adverse Events and Other Adverse Events: Safety Population for the full study cohort included participants who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. | 2 | 593 | 70 | 589 | 218 | 589 |
| EG001 | Cenicriviroc 150 mg | Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months. | 6 | 1,185 | 159 | 1,180 | 425 | 1,180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic valve disease mixed | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the male population. |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoparathyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mesenteric panniculitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gallbladder empyema | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Vulval cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alkalosis hypochloraemic | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alkalosis hypokalaemic | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mixed connective tissue disease | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the male population. |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Basosquamous carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Brain neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Endometrial neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Malignant melanoma of eyelid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Tumour of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Device dislocation | Product Issues | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the male population. |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment | Number of participants at risk in each arm is based on the female population. |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Phlebolith | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2020 | Dec 22, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506967 | cenicriviroc |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio (OR) |
| 0.8369 |
| 2-Sided |
| 95 |
| 0.6341 |
| 1.1044 |
Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline). |
| Superiority |
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months. |
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