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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   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:2016-004754-15
    Sponsor's Protocol Code Number:3152-201-002
    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:2017-05-08
    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 number2016-004754-15
    A.3Full title of the trial
    Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the long-term safety of the drug Cenicriviroc in people with liver disease.
    A.4.1Sponsor's protocol code number3152-201-002
    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, 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
    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
    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
    The primary objective of this study is to provide open-label treatment with CVC to subjects who have previously participated in CVC studies.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to assess the long-term safety of continued treatment with CVC for subjects who have previously participated in CVC studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For a subject to be eligible for participation in this study, all of the following criteria must apply.

    1. Subjects who have either:
    • Completed both Treatment Period 1 and Treatment Period 2, of the CENTAUR study (652-2-203), including a Year 2 liver biopsy
    • Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
    o Histopathologic progression to cirrhosis
    o Model for end-stage liver disease (MELD) score ≥ 15
    o Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
    o 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)
    2. Has been determined to be in a stable medical condition (minimum of 3 months from the date of the clinical event in AURORA to the Baseline Visit of this study) based on medical history or physical examination, in the opinion of investigator. Inclusion criterion applies only to subjects coming from the AURORA study (3152-301-002).
    3. Must provide a signed written informed consent form
    4. Females of child-bearing potential and males participating in the study must agree to use at least 2 approved barrier 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 without an alternative medical cause. Follicle stimulating hormone (FSH) level in the postmenopausal range (≥ 30 mU/mL) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
    a) Females on HRT and whose menopausal status is in doubt will be required to use the contraception methods in Section 20.3 if they wish to continue their HRT during the
    study. Otherwise, they must temporarily discontinue HRT to enable confirmation of postmenopausal status before study enrollment.
    E.4Principal exclusion criteria
    A subject will not be eligible for participation in this study if any of the following criteria apply.
    1. Any clinically significant change in the subject’s medical history or condition which, in the opinion of the investigator, would preclude administration of open-label CVC, including laboratory tests
    2. Prior or planned liver transplantation
    3. Other known causes of chronic liver disease, such as the following:
    • Alcoholic liver disease
    • Primary biliary cirrhosis
    • Primary sclerosing cholangitis
    • Autoimmune hepatitis
    • Wilson’s disease, hemochromatosis, or iron overload
    • Alpha-1-antitrypsis (A1AT) deficiency
    4. Females who are pregnant or breastfeeding
    5. 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.
    6. Currently receiving or planning to use any other investigational NASH treatment during the study
    7. 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 low risk of recurrence (ie, Oncotype DX 12 gene recurrence score < 30 for stage II or lower colon cancer; early-stage, estrogen-receptor positive, HER2-negative breast cancers that haven’t 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)
    E.5 End points
    E.5.1Primary end point(s)
    Long-term safety assessment of CVC administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once Cenicriviroc is commercially available or if development is discontinued
    E.5.2Secondary end point(s)
    Safety assessments including adverse events, hematology profile, chemistry profile, coagulation profile and serum chemistry
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, and every 3 months thereafter until study discontinued
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA150
    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
    Israel
    Italy
    Mexico
    New Zealand
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Slovenia
    Spain
    Switzerland
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    When the drug product becomes commercially available or if the study is discontinued by the Sponsor
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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: 420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 560
    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)
    CVC treatment will continue to be provided until it is commercially available or if development is terminated, as applicable.
    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 Decision2017-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-21
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