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Efficacy and Safety Study of Cenicriviroc for the Treatment of NASH in Adult Subjects With Liver Fibrosis (CENTAUR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02217475
First received: August 13, 2014
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to determine whether Cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.

Condition Intervention Phase
Nonalcoholic Steatohepatitis Drug: Cenicriviroc Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

Resource links provided by NLM:


Further study details as provided by Tobira Therapeutics, Inc.:

Primary Outcome Measures:
  • Histological improvement in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) score with no concurrent worsening of fibrosis stage (NASH CRN system) [ Time Frame: Year 1 ]
    Defined by a minimum 2-point improvement in NAS with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning


Secondary Outcome Measures:
  • Complete resolution of steatohepatitis with no concurrent worsening of fibrosis stage [ Time Frame: Year 1 ]
  • Improvement in fibrosis by at least 1 stage (NASH CRN system) with no worsening of steatohepatitis [ Time Frame: Years 1 and 2 ]

Other Outcome Measures:
  • Complete resolution of steatohepatitis with no concurrent worsening of fibrosis stage [ Time Frame: Year 2 ]
  • Improvement of fibrosis by at least one stage (NASH CRN system) with no worsening of steatohepatitis [ Time Frame: Year 2 ]
  • Change in histologic fibrosis stage [ Time Frame: Years 1 and 2 ]
    NASH CRN and Ishak systems

  • Safety and tolerability of cenicrivroc [ Time Frame: Years 1 and 2 ]
  • Characterize the pharmacokinetics of cenicriviroc [ Time Frame: Years 1 and 2 ]
  • Histological improvement in NAS with no concurrent worsening of fibrosis stage (NASH CRN system) [ Time Frame: Year 2 ]
  • Evaluate changes in the categorical features of NAS [ Time Frame: Years 1 and 2 ]
  • Evaluate change in quantitative collagen content on liver biopsy [ Time Frame: Years 1 and 2 ]
  • Evaluate change in hepatic tissue fibrogenic protein (alpha-Smooth Muscle Actin) [ Time Frame: Years 1 and 2 ]
  • Evaluate change in noninvasive hepatic fibrosis indices [ Time Frame: Years 0.25, 0.5, 1, 1.25, 1.5, and 2 ]
  • Evaluate change in biomarkers of hepatocyte apoptosis (cytokeratin-18) [ Time Frame: Years 0.25, 0.5, 1, 1.25, 1.5, and 2 ]
  • Evaluate change in liver and metabolic parameters [ Time Frame: Years 0.25, 0.5, 1, 1.25, 1.5, and 2 ]
  • Evaluate change in weight, BMI, and waist circumference [ Time Frame: Years 0.25, 0.5, 1, 1.25, 1.5, and 2 ]

Enrollment: 289
Study Start Date: September 2014
Estimated Study Completion Date: October 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cenicriviroc
Cenicriviroc 150mg tablet once daily in the morning with food for 2 years
Drug: Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food
Other Name: CVC
Experimental: Placebo + Cenicriviroc
Placebo once daily in the morning with food for year 1 then Cenicriviroc 150 mg tablet once daily in the morning with food for year 2
Drug: Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food
Other Name: CVC
Drug: Placebo
Placebo administered orally once daily and taken every morning with food
Other Name: PBO
Placebo Comparator: Placebo
Placebo once daily in the morning with food for 2 years
Drug: Placebo
Placebo administered orally once daily and taken every morning with food
Other Name: PBO

  Eligibility

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

Inclusion Criteria:

  • Adult subjects aged between 18-75
  • Histological evidence of NASH, based on biopsy, with a NAS of >= 4 with at least 1 in each component of NAS
  • Histological evidence of liver fibrosis defined as NASH 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/m2) 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)
  • AST and ALT ≤ 5 × upper limit of normal (ULN)

Exclusion Criteria:

  • Hepatitis B surface Antigen (HBsAg) positive
  • Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:

    1. Subjects 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. Subjects with presence of hepatitis C antibody but negative hepatitis C virus 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])
  • 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 subject unsuitable for the study or unable to comply with the dosing and protocol requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02217475

  Show 80 Study Locations
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
Study Director: Eric Lefebvre, MD Tobira Therapeutics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02217475     History of Changes
Other Study ID Numbers: 652-2-203
Study First Received: August 13, 2014
Last Updated: July 19, 2016

Additional relevant MeSH terms:
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
TAK-652
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 27, 2017