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Trial record 2 of 35 for:    Aurora Nash

Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059446
Recruitment Status : Terminated (This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.)
First Posted : February 23, 2017
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Brief Summary:
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Liver Cirrhosis Non-alcoholic Fatty Liver Disease Drug: Cenicriviroc Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : January 5, 2021


Arm Intervention/treatment
Experimental: Cenicriviroc
Cenicriviroc (CVC) 150 mg tablet once daily in the morning with food until CVC is commercially available or the study is terminated.
Drug: Cenicriviroc
Cenicriviroc 150 mg tablet once daily in the morning with food.
Other Name: CVC




Primary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (AE) [ Time Frame: Day 1 until the drug is commercially available or the study is terminated (Approximately 2 Years) ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
  • Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
  • Histopathological progression to cirrhoses
  • Model for end-stage liver disease (MELD) score ≥ 15
  • Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
  • Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalophathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture)

Exclusion Criteria:

  • Prior or planned liver transplantation
  • Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1-antitrypsis (A1AT) deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059446


Locations
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United States, Alabama
Digestive Health Specialists of the Southeast - Dothan
Dothan, Alabama, United States, 36305
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
United States, California
Franco Felizarta, MDv
Bakersfield, California, United States, 93301
University of California, San Diego (UCSD)
La Jolla, California, United States, 92037
Inland Empire Liver Foundation
Rialto, California, United States, 92377
University of California, San Diego (UCSD) - Medical Center
San Diego, California, United States, 92093
Quest Clinical Research
San Francisco, California, United States, 94115
Upland Clinical Research
Upland, California, United States, 91786
Island View Gastroenterology Associates
Ventura, California, United States, 93003
United States, Florida
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
Advanced Medical Research
Port Orange, Florida, United States, 32127
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas Medical Clinic PA
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
United States, Louisiana
Delta Research Partners, Llc
Bastrop, Louisiana, United States, 71220
Tandem Clinical Research LLC
Marrero, Louisiana, United States, 70072
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, United States, 21202
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States, 55114
United States, Mississippi
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
United States, New York
University of Buffalo - Erie County Medical Center
Buffalo, New York, United States, 14215
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Duke University Medical Center (DUMC)
Durham, North Carolina, United States, 27710
Wake Research Associates, LLC - Raleigh
Raleigh, North Carolina, United States, 27612
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research - Cincinnati
Cincinnati, Ohio, United States, 45249
United States, Oklahoma
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
ClinSearch LLC
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
Digestive Health Research
Lebanon, Tennessee, United States, 37090
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8887
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, United States, 77030
Pinnacle Clinical Research
Live Oak, Texas, United States, 78233
The Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States, 22031-4652
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, United States, 23249
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Swedish Medical Center
Seattle, Washington, United States, 98104
Australia, Queensland
Royal Brisbane Hospital and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austin Health
Heidelberg, Victoria, Australia, 3084
Austria
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Belgium
UCL Saint Luc Bruxelles
Brussel, Belgium, 1200
University Hospital Erasmus (Brussels)
Bruxelles, Belgium, 1070
Antwerp University Hospital (UZA)
Edegem, Belgium, 2650
Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
San Paulo, Brazil, 05403
France
CHU Angers
Angers Cedex 09, France, 49933
Hopital Saint Antoine
Paris, France, 75012
Hospital Pitie Salpetriere
Paris, France, 75013
Purpan CHU Toulouse
Toulouse, cedex 9, France, 31059
Germany
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Charite - University Hospital Berlin - Campus Virchow - Hospital
Berlin, Germany, 13353
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Universitaetsklinikum Heidelberg - Innere Medizin IV
Heidelberg, Germany, 69120
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
Koeln, Germany, 50937
Eugastro GmbH
Leipzig, Germany, 4103
University Hospital Giessen and Marburg GmbH
Marburg, Germany, 35043
Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong, Hong Kong
Israel
The Chaim Sheba Medical Center - Tel Hashomer
Tel-Hashomer, Israel, 52621
Italy
Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milano, Italy, 20122
AOU Policlinico Paolo Giaccone di Palermo
Palermo, Italy, 90127
Clinical Institute Humanitas - Humanitas Foundation for Research
Rozzano (MI), Italy, 20089
New Zealand
Auckland City Hospital
Grafton, Auckland N, New Zealand, 1010
Poland
ID Clinic
Myslowice, Poland, 41-400
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, Poland, 50-349
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 927
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 8022
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, Spain, 8026
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Switzerland
Kantonsspital St.Gallen Klinik für Gastroenterologie und Hepatologie
St.Gallen, Switzerland, 9007
United Kingdom
Nottingham NHS Treatment Centre
Nottingham, United Kingdom, NG7 2UH
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
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Study Director: Eduardo B Martins Allergan
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Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03059446    
Other Study ID Numbers: 3152-201-002
2016-004754-15 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Non-alcoholic Fatty Liver Disease
Liver Diseases
Fatty Liver
Liver Cirrhosis
Digestive System Diseases
TAK-652
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents