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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-004566-26
    Sponsor's Protocol Code Number:3152-301-002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-004566-26
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study of an investigational drug, Cenicriviroc, for the treatment of liver fibrosis in patients with Nonalcoholic Steatohepatitis (NASH).
    A.3.2Name or abbreviated title of the trial where available
    AURORA
    A.4.1Sponsor's protocol code number3152-301-002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTobira Therapeutics Inc., a subsidiary of Allergan plc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTobira Therapeutics Inc., a subsidiary of Allergan plc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTobira Therapeutics, Inc., a subsidiary of Allergan plc
    B.5.2Functional name of contact pointBosco D'Sa
    B.5.3 Address:
    B.5.3.1Street Address701 Gateway Blvd, Suite 300
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1714246-2273
    B.5.5Fax number+1714796-3015
    B.5.6E-mailDsa_Bosco@allergan.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCenicriviroc Mesylate
    D.3.2Product code CVC
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCENICRIVIROC MESYLATE
    D.3.9.1CAS number 497223-25-3
    D.3.9.2Current sponsor codeCENICRIVIROC
    D.3.9.3Other descriptive nameTBR-652
    D.3.9.4EV Substance CodeSUB180705
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Liver fibrosis in Subjects with Nonalcoholic Steatohepatitis
    E.1.1.1Medical condition in easily understood language
    Fatty Liver where the cells in the liver have abnormal fat built-up and built-up of scar tissue in the liver.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective (Part 1):
    •Demonstrate the superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy in adult
    subjects with a liver biopsy diagnosis of NASH and Stage 2 or 3 liver fibrosis (by NASH CRN system) as confirmed by an independent central
    pathologist
    Primary Objective (Part 2):
    •Demonstrate the superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, (defined
    by NASH CRN Fibrosis Stage 4), liver-related clinical outcomes, and all-cause mortality, as measured by the time to first occurrence of any of the listed adjudicated events (clinical outcomes composite endpoint) – (all subjects)
    E.2.2Secondary objectives of the trial
    Part 1:
    Evaluate the effect of CVC compared to placebo on liver histology at Month 12 relative to the screening biopsy for the proportion of subjects with improvement in fibrosis of at least 2 stages (NASH CRN system) AND no worsening of steatohepatitis
    Part 1 and 2:Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis.
    Part 1 and 2:Evaluate the safety and tolerability of CVC for the treatment of liver fibrosis in adult subjects with NASH.
    Part 2:Evaluate the effect of CVC compared to placebo on liver histology relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenetic testing
    The goal of this research is to find variations in DNA that will help identify persons with Liver Fibrosis with Nonalcoholic Steatohepatitis that will have the best response with CVC or to identify persons who will have fewer side effects in order to maximize their benefit from CVC.
    E.3Principal inclusion criteria
    1. Male and female subjects aged between 18-75 years
    2. Ability to understand and sign a written informed consent form (ICF)
    3. Histological evidence of NASH based on central reading of the screening liver biopsy slides
    4. Subjects included in Part1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the biopsy slides. Subjects 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.
    5. 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.
    E.4Principal exclusion criteria
    1. Inability to undergo a liver biopsy safely
    2. Hepatitis B surface antigen (HBsAg) positive
    3. Hepatitis C antibody (HCVAb) positive
    4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
    5. Prior or planned liver transplantation
    6. Other known causes of chronic liver disease
    7. History or presence of cirrhosis (NASH CRN Fibrosis Stage 4) and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
    8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
    9. AST > 5 × upper limit of normal (ULN) at Screening
    10. ALT > 5 × ULN at Screening
    11. HbA1c > 9% at Screening
    12. Serum albumin < 3.5 g/dL
    13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation at Screening
    14. Platelet count < 100,000/mm3 at Screening
    15. Total bilirubin > 1.3 mg/dL (subjects with hyperbilirubinemia associated with documented Gilbert’s syndrome may be eligible upon review by the medical monitor) at Screening
    16. International normalized ratio (INR) > 1.3
    17. Model of end stage liver disease (MELD) score > 12
    18. 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)
    19. Known history of hepatocellular carcinoma (HCC) at any time, history of malignancy within the past 5 years or ongoing malignancy other than: basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated stage II or lower colorectal or breast cancer in remission for ≥ 2 years and with documented low risk of recurrence (including but not limited to Oncotype DX 12 gene recurrence score <30 for stage II or lower colon cancer; early-stage, estrogen-receptor-positive, HER2-negative breast cancers that have not spread to the lymph nodes; Oncotype DX 21 gene recurrence score <18 for early stage invasive breast cancer; or Oncotype DX ductal carcinoma in situ [DCIS] 12 gene recurrence score <39 for noninvasive breast cancer)
    20. Active, serious infections that require parenteral therapy (antibiotic or antifungal) within 30 days prior to Screening visit
    21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
    22. Females who are pregnant or breastfeeding
    23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immune-modulating agents (such as
    systemic corticosteroids, interleukins, interferons)
    24. 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 SGLT1 inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Subjects 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, subjects need to be on stable therapy for at least 6 months prior to the day historical liver biopsy) was performed).
    25. Receiving ongoing therapy with any disallowed medication during the conduct of the study. Disallowed medication in use prior to
    enrollment will be required to be discontinued. For medications that are disallowed due to significant drug interactions with CVC, a washout
    period of 14 days or 5 half-lives, whichever is longer, must be observed prior to Baseline. For medications that are disallowed due to potential
    confounding effect on efficacy, a washout period of at least 6 months must be observed prior to the Screening liver biopsy. (Note: subjects
    receiving allowed concomitant medications need to be on stable therapy for at least 30 days prior to the Baseline visit, except for medications
    listed in exclusion criterion 24.)
    26. Allergy to the study drug or its components
    27. Receiving any investigational products within 30 days prior to Screening or anticipated use during the study
    28. Receiving any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 6 months prior to the Screening liver biopsy (subjects documented to be assigned to placebo in such trials may be eligible immediately following completion of their participation in the previous study)
    29. Participation in any other clinical study at Screening without approval from the sponsor
    30. 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
    E.5 End points
    E.5.1Primary end point(s)
    (Part 1): Proportion of subjects with improvement in fibrosis by 2 stages (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade)
    (Part 2): Time to first occurrence of any of the following adjudicated events:
    Death (all cause), Histopathologic progression to cirrhosis (defined by NASH CRN Fibrosis Stage 4), Liver transplant, MELD score ≥15, Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic), Hospitalization (as defined by a stay of ≥ 24 hours) for onset of: variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: Month 12
    Part 2: Duration of study
    E.5.2Secondary end point(s)
    Parts 1 and 2:
    Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver histology at Month 12 relative to the screening biopsy.
    Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on steatohepatitis, relative to the Screening biopsy.
    Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system), regardless of effect on steatohepatitis, at Month 12 relative to the screening biopsy.
    Part 2: Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis (no worsening of lobular inflammation or hepatocellular ballooning grade) on liver biopsy relative to the Screening biopsy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 12 and 60
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA155
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Mexico
    New Zealand
    Norway
    Peru
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Singapore
    Slovenia
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The primary analysis of Part 1 will occur when approximately 1200 randomized subjects have been followed for at least 12 months. The primary analysis for Part 2 will occur when adjudicated events have been accrued in approximately 367 unique subjects across Part 1 and Part 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 825
    F.4.2.2In the whole clinical trial 2000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Given the planned trial duration of approximately 8 years, subjects are expected to remain in the study until the potential marketing authorization or at the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-08
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