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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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
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Taoyuan
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England
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Lancaster
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London
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC)
for the treatment of liver fibrosis in adult participants with NASH.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03028740
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03028740