Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03028740




Registration number
NCT03028740
Ethics application status
Date submitted
13/01/2017
Date registered
23/01/2017
Date last updated
10/03/2022

Titles & IDs
Public title
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
Scientific title
AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis
Secondary ID [1] 0 0
2016-004566-26
Secondary ID [2] 0 0
3152-301-002
Universal Trial Number (UTN)
Trial acronym
AURORA
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 - Placebo
Treatment: Drugs - Cenicriviroc

Placebo comparator: Placebo - Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.

Experimental: Cenicriviroc 150 mg - Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.


Treatment: Drugs: Placebo
Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.

Treatment: Drugs: Cenicriviroc
Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Month 12
Primary outcome [2] 0 0
Time to First Occurrence of Adjudicated Events in the Full Study Cohort
Timepoint [2] 0 0
From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Month 12
Secondary outcome [2] 0 0
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
Timepoint [3] 0 0
Month 12
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Month 12
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Month 12
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Month 12
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Month 12
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Month 60
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Month 60
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Month 60
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Month 60

Eligibility
Key inclusion criteria
* Male and female participants aged between 18-75 years
* Ability to understand and sign a written informed consent form (ICF)
* Histological evidence of NASH based on central reading of the Screening biopsy
* Participants included in Part 1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
* Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for =12 months and serum follicle-stimulating hormone (FSH) =30 milliunits (mU)/milliliter (mL) at Screening.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to undergo a liver biopsy
* Hepatitis B surface antigen (HBsAg) positive
* Hepatitis C antibody (HCVAb) positive
* Human immunodeficiency virus (HIV)-1 or HIV-2 infection
* Prior or planned liver transplantation
* Other known causes of chronic liver disease
* History or presence 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
* Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males and females at Screening
* Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
* Hemoglobin A1c (HbA1c) >10% at Screening
* Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
* Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2 according to the Modification of Diet in Renal Disease (MDRD) equation
* Platelet count <100,000/millimeter (mm)^3
* Total bilirubin >1.5 milligram (mg)/dL
* International normalized ratio (INR) >1.3
* Model of end stage liver disease (MELD) score >12
* Weight reduction, defined as =7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
* History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
* Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
* Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
* Females who are pregnant or breastfeeding
* Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
* Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2021
Sample size
Target
Accrual to date
Final
1778
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Saint George Hospital - Kogarah
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
Austria
State/province [36] 0 0
Styria
Country [37] 0 0
Austria
State/province [37] 0 0
Tyrol
Country [38] 0 0
Austria
State/province [38] 0 0
Upper Austria
Country [39] 0 0
Belgium
State/province [39] 0 0
Antwerpen
Country [40] 0 0
Belgium
State/province [40] 0 0
Brussels
Country [41] 0 0
Belgium
State/province [41] 0 0
Oost-Vlaanderen
Country [42] 0 0
Belgium
State/province [42] 0 0
Liege
Country [43] 0 0
Brazil
State/province [43] 0 0
Minas Gerais
Country [44] 0 0
Brazil
State/province [44] 0 0
Sao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
Rio de Janeiro
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
Chile
State/province [50] 0 0
Valparaiso
Country [51] 0 0
France
State/province [51] 0 0
Alsace
Country [52] 0 0
France
State/province [52] 0 0
Aquitaine
Country [53] 0 0
France
State/province [53] 0 0
Aubergne
Country [54] 0 0
France
State/province [54] 0 0
Bretagne
Country [55] 0 0
France
State/province [55] 0 0
Franche-Comte
Country [56] 0 0
France
State/province [56] 0 0
Ile-De-France
Country [57] 0 0
France
State/province [57] 0 0
Ile-de-France
Country [58] 0 0
France
State/province [58] 0 0
Languedoc-Roussillon
Country [59] 0 0
France
State/province [59] 0 0
Normandie
Country [60] 0 0
France
State/province [60] 0 0
Pays De La Loire
Country [61] 0 0
France
State/province [61] 0 0
Picardie
Country [62] 0 0
France
State/province [62] 0 0
Provence Alpes Cote D'Azur
Country [63] 0 0
France
State/province [63] 0 0
Rhone-Alpes
Country [64] 0 0
France
State/province [64] 0 0
Bobigny
Country [65] 0 0
Germany
State/province [65] 0 0
Hessen
Country [66] 0 0
Germany
State/province [66] 0 0
Niedersachsen
Country [67] 0 0
Germany
State/province [67] 0 0
Nordhein-Westfalen
Country [68] 0 0
Germany
State/province [68] 0 0
Nordrhein-Westfalen
Country [69] 0 0
Germany
State/province [69] 0 0
Nordrhein-westfalen
Country [70] 0 0
Germany
State/province [70] 0 0
Rheinland-Pfalz
Country [71] 0 0
Germany
State/province [71] 0 0
Saarland
Country [72] 0 0
Germany
State/province [72] 0 0
Sachsen
Country [73] 0 0
Germany
State/province [73] 0 0
Berlin
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Greece
State/province [75] 0 0
Peloponnese
Country [76] 0 0
Greece
State/province [76] 0 0
Thessaloniki
Country [77] 0 0
Hong Kong
State/province [77] 0 0
New Territories
Country [78] 0 0
Hungary
State/province [78] 0 0
Somogy
Country [79] 0 0
Hungary
State/province [79] 0 0
Budapest
Country [80] 0 0
Hungary
State/province [80] 0 0
Debrecen
Country [81] 0 0
Israel
State/province [81] 0 0
Jerusalem
Country [82] 0 0
Israel
State/province [82] 0 0
Haifa
Country [83] 0 0
Israel
State/province [83] 0 0
Nahariya
Country [84] 0 0
Israel
State/province [84] 0 0
Petah Tikva
Country [85] 0 0
Israel
State/province [85] 0 0
Tel Aviv
Country [86] 0 0
Israel
State/province [86] 0 0
Tel-Hashomer
Country [87] 0 0
Italy
State/province [87] 0 0
Foggia
Country [88] 0 0
Italy
State/province [88] 0 0
Milano
Country [89] 0 0
Italy
State/province [89] 0 0
Firenze
Country [90] 0 0
Italy
State/province [90] 0 0
Palermo
Country [91] 0 0
Italy
State/province [91] 0 0
Roma
Country [92] 0 0
Latvia
State/province [92] 0 0
Riga
Country [93] 0 0
Mexico
State/province [93] 0 0
Distrito Federal
Country [94] 0 0
Mexico
State/province [94] 0 0
Morelos
Country [95] 0 0
Mexico
State/province [95] 0 0
Nuevo Leon
Country [96] 0 0
Mexico
State/province [96] 0 0
Metepec
Country [97] 0 0
New Zealand
State/province [97] 0 0
Auckland
Country [98] 0 0
Norway
State/province [98] 0 0
Oslo
Country [99] 0 0
Poland
State/province [99] 0 0
Dolnoslaskie
Country [100] 0 0
Poland
State/province [100] 0 0
Lodzkie
Country [101] 0 0
Poland
State/province [101] 0 0
Lodz
Country [102] 0 0
Poland
State/province [102] 0 0
Slaskie
Country [103] 0 0
Poland
State/province [103] 0 0
Wielkopolska
Country [104] 0 0
Poland
State/province [104] 0 0
Wroclaw
Country [105] 0 0
Poland
State/province [105] 0 0
Czestochowa
Country [106] 0 0
Poland
State/province [106] 0 0
Gdansk
Country [107] 0 0
Poland
State/province [107] 0 0
Gdynia
Country [108] 0 0
Poland
State/province [108] 0 0
Katowice
Country [109] 0 0
Poland
State/province [109] 0 0
Warsaw
Country [110] 0 0
Portugal
State/province [110] 0 0
Lordelo
Country [111] 0 0
Portugal
State/province [111] 0 0
Viana do Castelo
Country [112] 0 0
Puerto Rico
State/province [112] 0 0
San Juan
Country [113] 0 0
Romania
State/province [113] 0 0
Cluj
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
Country [115] 0 0
Singapore
State/province [115] 0 0
Singapore
Country [116] 0 0
Spain
State/province [116] 0 0
Barcelona
Country [117] 0 0
Spain
State/province [117] 0 0
Guipuzcoa
Country [118] 0 0
Spain
State/province [118] 0 0
Almeria
Country [119] 0 0
Spain
State/province [119] 0 0
Madrid
Country [120] 0 0
Spain
State/province [120] 0 0
Málaga
Country [121] 0 0
Spain
State/province [121] 0 0
Santander
Country [122] 0 0
Spain
State/province [122] 0 0
Sevilla
Country [123] 0 0
Spain
State/province [123] 0 0
Valencia
Country [124] 0 0
Switzerland
State/province [124] 0 0
Saint Gallen
Country [125] 0 0
Switzerland
State/province [125] 0 0
Bern
Country [126] 0 0
Taiwan
State/province [126] 0 0
Chiayi
Country [127] 0 0
Taiwan
State/province [127] 0 0
Taichung City
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taoyuan
Country [129] 0 0
United Kingdom
State/province [129] 0 0
England
Country [130] 0 0
United Kingdom
State/province [130] 0 0
West Yorkshire
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Hexham
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Lancaster
Country [133] 0 0
United Kingdom
State/province [133] 0 0
London
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Manchester

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
Gerardo Rodriguez
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03028740