Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
NCT ID: NCT02217475
Last Updated: 2019-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2014-09-18
2017-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Cenicriviroc (CVC) 150mg/CVC 150 mg
CVC 150 mg tablet in Years 1 and 2.
Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food.
Placebo/CVC 150 mg
Placebo-matching CVC tablet in Year 1 then CVC 150 mg tablet in Year 2.
Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food.
Placebo
Placebo administered orally once daily and taken every morning with food.
Placebo/Placebo
Placebo-matching cenicriviroc (CVC) tablet in Years 1 and 2.
Placebo
Placebo administered orally once daily and taken every morning with food.
Interventions
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Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food.
Placebo
Placebo administered orally once daily and taken every morning with food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological evidence of NASH, based on biopsy, with a Nonalcoholic fatty liver disease Activity Score (NAS) of \>= 4 with at least 1 in each component of NAS
* Histological evidence of liver fibrosis defined as NASH Clinical Research Network (CRN) System Stage 1 to 3
* Meeting any of the 3 major criteria (a, b, c):
1. Documented evidence of type 2 diabetes mellitus
2. High body mass index (\> 25 kg/m\^2) with at least one of the following criteria of metabolic syndrome, as defined by the National Cholesterol Education Program:
* Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches (female)
* Dyslipidemia: Triglycerides ≥ 1.7 mmol/L (150 mg/dL)
* Dyslipidemia: High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL (male), \< 50 mg/dL (female)
* Blood pressure ≥ 130/85 mmHg (or currently being treated for hypertension)
* Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dL)
3. Bridging fibrosis (NASH CRN Stage 3) and/or definite NASH (NAS ≥ 5)
* Agree to have one liver biopsy at Screening, one at Year 1, and one at the end of study treatment (Year 2)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)
Exclusion Criteria
* Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:
1. Participants previously treated for viral hepatitis C with at least a 1-year period since documented sustained virologic response at Week 12 (post-treatment) may be eligible if all other eligibility criteria are met
2. Participants with presence of hepatitis C antibody but negative hepatitis C virus ribonucleic acid RNA without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met
* Prior or planned liver transplantation
* Other known causes of chronic liver disease, including alcoholic liver disease
* History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
* Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer \[285 mL\], 1 glass of spirits \[25 mL\] or 1 glass of wine \[125 mL\])
* Human immunodeficiency virus (HIV)-1 or HIV-2 infection
* Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
* Females who are pregnant or breastfeeding
* Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing and protocol requirements.
18 Years
75 Years
ALL
No
Sponsors
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Tobira Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Lefebvre, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Dothan, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Rialto, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Littleton, Colorado, United States
Miami, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Saint Paul, Minnesota, United States
Flowood, Mississippi, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
Buffalo, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Live Oak, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Garran, Australian Capital Territory, Australia
Herston, Queensland, Australia
Adelaide, South Australia, Australia
Bedford Park, South Australia, Australia
Clayton, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Leuven, , Belgium
Angers, , France
Lyon, , France
Montpellier, , France
Paris, , France
Paris, , France
Pessac, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Villejuif, , France
Heidelberg, Baden-Wurttemberg, Germany
Hamburg, City state of Hamburg, Germany
Marburg, Hesse, Germany
Hanover, Lower Saxony, Germany
Aachen, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Heidelberg, VIC, Germany
Berlin, , Germany
Lübeck, , Germany
Shatin, New Territories, Hong Kong
Bologna, BO, Italy
Milan, MI, Italy
Rozzano, MI, Italy
Palermo, PA, Italy
Chorzów, , Poland
Lodz, , Poland
Mysłowice, , Poland
Rzeszów, , Poland
Wroclaw, , Poland
Alicante, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Portsmouth, Hampshire, United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle, , United Kingdom
Nottingham, , United Kingdom
Countries
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References
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Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22.
Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.
Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22. No abstract available.
Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.
Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.
Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.
Other Identifiers
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2016-004754-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
652-2-203
Identifier Type: -
Identifier Source: org_study_id
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