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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02217475




Registration number
NCT02217475
Ethics application status
Date submitted
13/08/2014
Date registered
15/08/2014
Date last updated
10/05/2019

Titles & IDs
Public title
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
Scientific title
CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis
Secondary ID [1] 0 0
2016-004754-15
Secondary ID [2] 0 0
652-2-203
Universal Trial Number (UTN)
Trial acronym
CENTAUR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cenicriviroc
Treatment: Drugs - Placebo

Experimental: Cenicriviroc (CVC) 150mg/CVC 150 mg - CVC 150 mg tablet in Years 1 and 2.

Experimental: Placebo/CVC 150 mg - Placebo-matching CVC tablet in Year 1 then CVC 150 mg tablet in Year 2.

Placebo comparator: Placebo/Placebo - Placebo-matching cenicriviroc (CVC) tablet in Years 1 and 2.


Treatment: Drugs: Cenicriviroc
CVC 150 mg, administered orally once daily and taken every morning with food.

Treatment: Drugs: Placebo
Placebo administered orally once daily and taken every morning with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participant With Hepatic Histological Improvement in NAS by = 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1
Timepoint [1] 0 0
Year 1
Secondary outcome [1] 0 0
Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Timepoint [1] 0 0
Year 1
Secondary outcome [2] 0 0
Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Timepoint [2] 0 0
Year 2
Secondary outcome [3] 0 0
Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1
Timepoint [3] 0 0
Year 1
Secondary outcome [4] 0 0
Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2
Timepoint [4] 0 0
Year 2
Secondary outcome [5] 0 0
Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Timepoint [5] 0 0
Year 1
Secondary outcome [6] 0 0
Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Timepoint [6] 0 0
Year 2
Secondary outcome [7] 0 0
Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation
Timepoint [7] 0 0
Years 1 and 2
Secondary outcome [8] 0 0
Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [8] 0 0
Years 1 and 2
Secondary outcome [9] 0 0
Number of Participants With Clinical Laboratory Abnormalities
Timepoint [9] 0 0
Years 1 and 2
Secondary outcome [10] 0 0
Number of Participants With Clinically Abnormal in Electrocardiogram (ECG) Findings
Timepoint [10] 0 0
Years 1 and 2
Secondary outcome [11] 0 0
Number of Participants With Hepatic Histological Improvement in NAS at Year 2
Timepoint [11] 0 0
Year 2
Secondary outcome [12] 0 0
Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 1
Timepoint [12] 0 0
Year 1
Secondary outcome [13] 0 0
Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 2
Timepoint [13] 0 0
Year 2
Secondary outcome [14] 0 0
Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-Point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Timepoint [14] 0 0
Year 1
Secondary outcome [15] 0 0
Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Timepoint [15] 0 0
Year 2
Secondary outcome [16] 0 0
Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Timepoint [16] 0 0
Year 1
Secondary outcome [17] 0 0
Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Timepoint [17] 0 0
Year 2
Secondary outcome [18] 0 0
Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 1
Timepoint [18] 0 0
Year 1
Secondary outcome [19] 0 0
Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 2
Timepoint [19] 0 0
Year 2
Secondary outcome [20] 0 0
Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (a-SMA) at Year 1
Timepoint [20] 0 0
Baseline (Day 1) to Year 1
Secondary outcome [21] 0 0
Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (a-SMA) at Year 2
Timepoint [21] 0 0
Baseline (Day 1) to Year 2
Secondary outcome [22] 0 0
Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 1
Timepoint [22] 0 0
Year 1
Secondary outcome [23] 0 0
Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 2
Timepoint [23] 0 0
Year 2
Secondary outcome [24] 0 0
Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 1
Timepoint [24] 0 0
Baseline (Day 1) to Year 1
Secondary outcome [25] 0 0
Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 2
Timepoint [25] 0 0
Baseline (Day 1) to Year 2
Secondary outcome [26] 0 0
Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 1
Timepoint [26] 0 0
Baseline (Day 1) to Year 1
Secondary outcome [27] 0 0
Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 2
Timepoint [27] 0 0
Baseline (Day 1) to Year 2
Secondary outcome [28] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 3, 6 and 12
Timepoint [28] 0 0
Baseline (Month 0) to Months 3, 6 and 12
Secondary outcome [29] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 15, 18 and 24
Timepoint [29] 0 0
Baseline (Month 0) to Months 15, 18 and 24
Secondary outcome [30] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 3, 6 and 12
Timepoint [30] 0 0
Baseline (Month 0) to Months 3, 6 and 12
Secondary outcome [31] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 15, 18 and 24
Timepoint [31] 0 0
Baseline (Month 0) to Months 15, 18 and 24
Secondary outcome [32] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 6 and 12
Timepoint [32] 0 0
Baseline (Month 0) to Months 6 and 12
Secondary outcome [33] 0 0
Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 18 and 24
Timepoint [33] 0 0
Baseline (Month 0) to Months 18 and 24
Secondary outcome [34] 0 0
Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) at Months 3, 6 and 12
Timepoint [34] 0 0
Baseline (Month 0) to Months 3, 6 and 12
Secondary outcome [35] 0 0
Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: NAFLD Fibrosis Score (NFS) at Months 15, 18 and 24
Timepoint [35] 0 0
Baseline (Month 0) to Months 15, 18 and 24
Secondary outcome [36] 0 0
Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 6 and 12
Timepoint [36] 0 0
Baseline (Month 0) to Months 6 and 12
Secondary outcome [37] 0 0
Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 18 and 24
Timepoint [37] 0 0
Baseline (Month 0) to Months 18 and 24
Secondary outcome [38] 0 0
Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 3, 6 and 12
Timepoint [38] 0 0
Baseline (Month 0) to Months 3, 6 and 12
Secondary outcome [39] 0 0
Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 15, 18 and 24
Timepoint [39] 0 0
Baseline (Month 0) to Months 15, 18 and 24
Secondary outcome [40] 0 0
Change From Baseline in Weight at Months 3, 6 and 12
Timepoint [40] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [41] 0 0
Change From Baseline in Weight at Months 15, 18 and 24
Timepoint [41] 0 0
Baseline (Day 1) to Months 15, 18 and 24
Secondary outcome [42] 0 0
Change From Baseline in Body Mass Index (BMI) at Months 3, 6 and 12
Timepoint [42] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [43] 0 0
Change From Baseline in Body Mass Index (BMI) at Months 15, 18 and 24
Timepoint [43] 0 0
Baseline (Day 1) to Months 15, 18 and 24
Secondary outcome [44] 0 0
Change From Baseline in Waist Circumference at Months 3, 6 and 12
Timepoint [44] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [45] 0 0
Change From Baseline in Waist Circumference at Months 15, 18 and 24
Timepoint [45] 0 0
Baseline (Day 1) to Months 15, 18 and 24
Secondary outcome [46] 0 0
Change From Baseline in Hip Circumference at Months 3, 6 and 12
Timepoint [46] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [47] 0 0
Change From Baseline in Hip Circumference at Months 15, 18 and 24
Timepoint [47] 0 0
Baseline (Day 1) to Months 15, 18 and 24
Secondary outcome [48] 0 0
Change From Baseline in Forearm Circumference at Months 3, 6 and 12
Timepoint [48] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [49] 0 0
Change From Baseline in Forearm Circumference at Months 15, 18 and 24
Timepoint [49] 0 0
Baseline (Day 1) to Months 15, 18 and 24
Secondary outcome [50] 0 0
Change From Baseline in Tricep Skinfold Thickness at Months 3, 6 and 12
Timepoint [50] 0 0
Baseline (Day 1) to Months 3, 6 and 12
Secondary outcome [51] 0 0
Change From Baseline in Tricep Skinfold Thickness at Months 15, 18 and 24
Timepoint [51] 0 0
Baseline (Day 1) to Months 15, 18 and 24

Eligibility
Key inclusion criteria
* Adult participants aged between 18-75
* 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hepatitis B surface Antigen (HBsAg) positive
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/06/2017
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Bedford Park
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Heidelberg
Recruitment hospital [7] 0 0
- Melbourne
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Edegem
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
France
State/province [25] 0 0
Angers
Country [26] 0 0
France
State/province [26] 0 0
Lyon cedex 04
Country [27] 0 0
France
State/province [27] 0 0
Montpellier Cedex 5
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Pessac Cedex
Country [30] 0 0
France
State/province [30] 0 0
Toulouse
Country [31] 0 0
France
State/province [31] 0 0
Vandoeuvre-les Nancy
Country [32] 0 0
France
State/province [32] 0 0
Villejuif
Country [33] 0 0
Germany
State/province [33] 0 0
BW
Country [34] 0 0
Germany
State/province [34] 0 0
HE
Country [35] 0 0
Germany
State/province [35] 0 0
HH
Country [36] 0 0
Germany
State/province [36] 0 0
Niedersachsen
Country [37] 0 0
Germany
State/province [37] 0 0
NRW
Country [38] 0 0
Germany
State/province [38] 0 0
Sachsen
Country [39] 0 0
Germany
State/province [39] 0 0
SN
Country [40] 0 0
Germany
State/province [40] 0 0
VIC
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Lubeck
Country [43] 0 0
Hong Kong
State/province [43] 0 0
New Territories
Country [44] 0 0
Italy
State/province [44] 0 0
BO
Country [45] 0 0
Italy
State/province [45] 0 0
MI
Country [46] 0 0
Italy
State/province [46] 0 0
PA
Country [47] 0 0
Poland
State/province [47] 0 0
Chorzow
Country [48] 0 0
Poland
State/province [48] 0 0
Lodz
Country [49] 0 0
Poland
State/province [49] 0 0
Myslowice
Country [50] 0 0
Poland
State/province [50] 0 0
Rzeszow
Country [51] 0 0
Poland
State/province [51] 0 0
Wroclaw
Country [52] 0 0
Spain
State/province [52] 0 0
Alicante
Country [53] 0 0
Spain
State/province [53] 0 0
Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Hampshire
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Newcastle
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tobira Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Lefebvre, MD
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02217475