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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination with Entecavir or Tenofovir in Patients with HBeAg Negative, Chronic Hepatits B Virus (HBV) Infection

    Summary
    EudraCT number
    		 2014-004145-27
    Trial protocol
    		 DE  
    Global end of trial date
    22 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2018
    First version publication date
    03 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Heparc-2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02604199
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Arrowhead Pharmaceuticals, Inc
    Sponsor organisation address
    225 S. Lake Avenue, Suite 1050, Pasadena, CA, United States, 91101
    Public contact
    Susan Boynton,, Arrowhead Pharmaceuticals, Inc, 001 626- 696-4707, sboynton@arrowheadpharma.com
    Scientific contact
    Susan Boynton,, Arrowhead Pharmaceuticals, Inc, 001 626- 696-4707, sboynton@arrowheadpharma.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
    22 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Objective: • To evaluate the depth of HBsAg decline in response to multiple doses of ARC-520 compared to PBO in patients with chronic HBV infection as a measure of drug activity
    Protection of trial subjects
    Subjects were advised that they were free to withdraw from the study at any time for any reason or, if necessary, the Principal Investigator, or medically trained designee, may have withdrawn a subject from the study, according to the following protocol specified criteria, to protect the subject's health: • the need to take medication which may have interfered with study measurements; • intolerable/unacceptable adverse experiences; • major violation or deviation of study protocol procedures; • non-compliance of participant with protocol; • subject unwilling to proceed and/or consent was withdrawn; or • withdrawal from the study if, in the Principal Investigator’s judgment, it was in the subject’s best interest.
    Background therapy
    		 All subjects continued to receiving daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period. Two hours (±30 minutes) prior to PBO or ARC-520 Injection intravenous (IV) administration, patients were pretreated with antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator was free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2015
    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
    Korea, Republic of: 23
    Country: Number of subjects enrolled
    Hong Kong: 19
    Country: Number of subjects enrolled
    Germany: 16
    Worldwide total number of subjects
    58
    EEA total number of subjects
    16
    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)
    56
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Potential subjects underwent Screening within 60 days of first dose administration to confirm eligibility to be enrolled and randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Blinding to treatment assignment will be maintained throughout the study period. Blinding will be achieved by the use of a PBO (matching) product (0.9% normal saline) to be administered intravenously.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PBO Low Dose
    Arm description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% normal saline placebo was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.

    Arm title
    		 PBO High Dose
    Arm description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.9% normal saline placebo was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.

    Arm title
    		 ARC-520 Injection 1 mg/kg
    Arm description
    		 Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
    Arm type
    		 Experimental

    Investigational medicinal product name
    ARC-520 Injection
    Investigational medicinal product code
    ARC-520
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    ARC-520 Injection was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.

    Arm title
    		 ARC-520 Injection 2 mg/kg
    Arm description
    		 Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period
    Arm type
    		 Experimental

    Investigational medicinal product name
    ARC-520 Injection
    Investigational medicinal product code
    ARC-520
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    ARC-520 Injection was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.

    Number of subjects in period 1
    		PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Started
    9
    11
    17
    21
    Completed
    9
    8
    17
    18
    Not completed
    0
    3
    0
    3
         Consent withdrawn by subject
    -
    1
    -
    -
         Pregnancy
    -
    -
    -
    1
         Study terminated by sponsor
    -
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PBO Low Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    PBO High Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 1 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 2 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg Total
    Number of subjects
    		 9 11 17 21 58
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.2 ± 12.10 48.7 ± 9.50 45.0 ± 10.48 45.7 ± 10.26 -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 7 9 19
        Male
    		 7 10 10 12 39

    End points

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    End points reporting groups
    Reporting group title
    PBO Low Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    PBO High Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 1 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 2 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Primary: Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113

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    End point title
    		 Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, Day 113
    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: This analysis was removed from the initial statistical analysis plan due to early study termination.
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: Log qHBsAg
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [2] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [3] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [4] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [5] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

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    End point title
    		 Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
    End point description
    An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.
    End point type
    Secondary
    End point timeframe
    Through Day 169
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    9
    11
    17
    21
    Units: subjects
        ≥ 1 AE
    4
    5
    6
    12
        ≥ 1 TEAE
    4
    4
    6
    12
        ≥ 1 Serious TEAE
    0
    0
    2
    1
        Deaths
    0
    0
    0
    0
        ≥ 1 TEAE Leading to Study Discontinuation
    0
    0
    0
    0
        ≥ 1 TEAE Leading to Treatment Discontinuation
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)

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    End point title
    		 Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [6] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [7] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [8] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [9] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)

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    End point title
    		 Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [10] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [11] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [12] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [13] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)

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    End point title
    		 Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: hr*ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [14] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [15] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [16] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [17] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [18] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [19] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [20] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [21] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Clearance (CL)

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    End point title
    		 Pharmacokinetics of ARC-520: Clearance (CL)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: mL/min
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [22] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [23] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [24] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [25] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)

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    End point title
    		 Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    Units: liters
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [26] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [27] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [28] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [29] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)

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    End point title
    		 Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    Units: 1/hour
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [30] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [31] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [32] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [33] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)

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    End point title
    		 Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
    End point description
    End point type
    Secondary
    End point timeframe
    Through 48 hours post-dosing on Day 1 and Day 85
    End point values
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    Units: hours
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    Notes
    [34] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [35] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [36] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    [37] - Analysis was removed from the initial statistical analysis plan due to early study termination.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through Day 169
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PBO Low Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    PBO High Dose
    Reporting group description
    		 0.9% normal saline, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 1 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 1.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Reporting group title
    ARC-520 Injection 2 mg/kg
    Reporting group description
    		 Intravenous ARC-520 at 2.0 mg/kg, once every 4 weeks for 4 doses plus daily oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg) throughout the study period

    Serious adverse events
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    2 / 17 (11.76%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PBO Low Dose PBO High Dose ARC-520 Injection 1 mg/kg ARC-520 Injection 2 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    4 / 11 (36.36%)
    4 / 17 (23.53%)
    8 / 21 (38.10%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    1
    Lethargy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 17 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    2
    Chills
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    1
    Fatigue
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    2
    Influenza like illness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    1
    Malaise
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    4
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 17 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 17 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 17 (5.88%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    1 / 17 (5.88%)
    3 / 21 (14.29%)
         occurrences all number
    1
    1
    1
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2015
    • The addition of venous lactate level to the schedule of assessments. • Changed post-dose observation period from 2 hours to 4 hours. • Clarified there was a risk of infusion-related reactions including both anaphylactic and non-anaphylactic or cytokine release syndrome. Addition of Cytokine Release Syndrome clinical management guidelines. Clinical guidelines for management of anaphylactic reactions were added. • Correction of administrative, grammatical, formatting errors, and inconsistencies.
    11 Apr 2016
    • Reduced the number of patients designated as PK patients from 24 to 12 patients. • Altered exclusion criteria 2, 6, 9, 11, 12, 13, 27, 28, 32, 34. • Removed exclusion criteria 7, 8, 20, 26, 30, 36, 37, 39. • Changes to the information presented in the Restrictions and Concomitant Medications section including removal of restriction from strenuous activity and changes to concomitant medications. • “Arrowhead Research Corporation” was changed to “Arrowhead Pharmaceuticals, Inc.” due to Sponsor name change.
    19 Oct 2016
    • Addition to the Exclusion Criteria and Study Restrictions information regarding planned surgery or non-emergent procedures requiring an induction agent to occur 48 hours before and after ARC-520 Injection administrations.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The ARC-520 Injection development program was terminated early for regulatory and business reasons secondary to findings occurring in a non-clinical toxicology study. Program termination was not due to safety findings in humans.
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    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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