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    Clinical Trial Results:
    Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (NASH)

    Summary
    EudraCT number
    		 2016-004754-15
    Trial protocol
    		 GB   DE   BE   ES   HU   AT   IT  
    Global end of trial date
    05 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2021
    First version publication date
    03 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3152-201-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03059446
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan
    Sponsor organisation address
    1st Floor, Marlow International, The Parkway, Marlow Buckinghamshire, United Kingdom, SL7 1YL
    Public contact
    Therapeutic Area, Head, Allergan, 001 714-246-4500, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area, Head, Allergan, 001 714-246-4500, IR-CTRegistration@Allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jan 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This rollover study provided open-label treatment with cenicriviroc and assessed the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 108
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Hong Kong: 6
    Worldwide total number of subjects
    167
    EEA total number of subjects
    42
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    121
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants who completed the CENTAUR study [NCT02217475] or the AURORA study [NCT03028740] were eligible for enrollment in this rollover study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cenicriviroc (CVC) 150 mg
    Arm description
    		 Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenicriviroc
    Investigational medicinal product code
    Other name
    CVC
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Cenicriviroc 150 mg immediate release tablet once daily in the morning with food.

    Number of subjects in period 1
    		Cenicriviroc (CVC) 150 mg
    Started
    167
    Completed
    0
    Not completed
    167
         Withdrawal of Consent
    16
         Adverse event, serious fatal
    1
         Adverse event, non-fatal
    10
         Study Terminated by Sponsor
    131
         Lost to follow-up
    3
         Reason not Specified
    5
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cenicriviroc (CVC) 150 mg
    Reporting group description
    		 Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).

    Reporting group values
    		 Cenicriviroc (CVC) 150 mg Total
    Number of subjects
    		 167 167
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 121 121
        From 65-84 years
    		 46 46
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.8 ± 10.41 -
    Sex: Female, Male
    Units: participants
        Female
    		 88 88
        Male
    		 79 79
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Asian
    		 9 9
        Native Hawaiian or Other Pacific Islander
    		 2 2
        Black or African American
    		 4 4
        White
    		 150 150
        More than one race
    		 0 0
        Unknown or Not Reported
    		 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 24 24
        Not Hispanic or Latino
    		 143 143
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cenicriviroc (CVC) 150 mg
    Reporting group description
    		 Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).

    Primary: Number of Participants With Treatment-emergent Adverse Events (AE)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (AE) [1]
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug. Safety Population included all participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 until the study was terminated (up to approximately 4 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses are reported for this endpoint.
    End point values
    		 Cenicriviroc (CVC) 150 mg
    Number of subjects analysed
    167
    Units: participants
    140
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 until the study was terminated (Up to approximately 4 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Cenicriviroc 150 mg
    Reporting group description
    		 Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).

    Serious adverse events
    		 Cenicriviroc 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    40 / 167 (23.95%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen’s disease
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ovarian cancer
    Additional description: Number of participants at risk is based on the female population.
         subjects affected / exposed [1]
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Post procedural fever
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Migraine with aura
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia legionella
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 167 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone abscess
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Q fever
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 167 (1.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gout
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 167 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Number of participants at risk is based on the female population.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cenicriviroc 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 167 (58.68%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 167 (5.99%)
         occurrences all number
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 167 (5.99%)
         occurrences all number
    11
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    20 / 167 (11.98%)
         occurrences all number
    27
    Abdominal pain upper
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    13
    Abdominal pain
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    14
    Nausea
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    19
    Constipation
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    13
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    13 / 167 (7.78%)
         occurrences all number
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    22 / 167 (13.17%)
         occurrences all number
    29
    Infections and infestations
    Influenza
         subjects affected / exposed
    14 / 167 (8.38%)
         occurrences all number
    14
    Nasopharyngitis
         subjects affected / exposed
    17 / 167 (10.18%)
         occurrences all number
    21
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    10
    Sinusitis
         subjects affected / exposed
    9 / 167 (5.39%)
         occurrences all number
    13
    Bronchitis
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    14
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    12 / 167 (7.19%)
         occurrences all number
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Jan 2021
    This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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