Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment – ADVANCE HCV Study

    Summary
    EudraCT number
    		 2017-001039-38
    Trial protocol
    		 GB  
    Global end of trial date
    28 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2021
    First version publication date
    21 Oct 2021
    Other versions
    Summary report(s)
    		 ADVANCE trial summary

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2016GA03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03236506
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor R&D number : 2016GA03
    Sponsors
    Sponsor organisation name
    University of Dundee
    Sponsor organisation address
    TASC, Ninewells Hospital, Level3, Dundee, United Kingdom, DD1 9SY
    Public contact
    Sarah Inglis, University of Dundee, Tayside Clinical Trials Unit, +44 01382383219, TASCgovernance@dundee.ac.uk
    Scientific contact
    Sarah Inglis, University of Dundee, Tayside Clinical Trials Unit, 1383383297 01382383219, TASCgovernance@dundee.ac.uk
    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
    20 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to identify which one of three methods of treatment is the most effective in curing hepatitis C infection in people who inject drugs. The three methods we are testing are: 1. patients receiving their medication daily at their local pharmacy or needle exchange, 2. patients receiving their medication on a fortnightly basis from the needle exchange, 3. patients receiving their medication on a fortnightly basis from the needle exchange AND getting help from a psychologist to remember to take their medicine every day.
    Protection of trial subjects
    Trial staff were trained to provide support if any participants became distressed during the trial visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 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
    United Kingdom: 135
    Worldwide total number of subjects
    135
    EEA total number of subjects
    0
    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)
    135
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 135 people who inject drugs were recruited from injecting provision sites in Tayside, Scotland between January 2018 and November 2019

    Pre-assignment
    Screening details
    		 6 participants chose not to take after being consented. 129 were randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Daily observed therapy
    Arm description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zepatier
    Investigational medicinal product code
    EU/1/16/1119/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One daily for either 12 weeks (Genotype 1 HCV infection) or 8 weeks (Genotype 3 infection)

    Investigational medicinal product name
    Sovaldi
    Investigational medicinal product code
    EU/1/13/894/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One per day for 8 weeks (Genotype 3 HCV infection only)

    Arm title
    		 Fortnightly Pick-up
    Arm description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zepatier
    Investigational medicinal product code
    EU/1/16/1119/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One daily for either 12 weeks (Genotype 1 HCV infection) or 8 weeks (Genotype 3 infection)

    Investigational medicinal product name
    Sovaldi
    Investigational medicinal product code
    EU/1/13/894/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One per day for 8 weeks (Genotype 3 HCV infection only)

    Arm title
    		 Fortnightly Pick-up with Psych intervention
    Arm description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of n
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zepatier
    Investigational medicinal product code
    EU/1/16/1119/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One daily for either 12 weeks (Genotype 1 HCV infection) or 8 weeks (Genotype 3 infection)

    Investigational medicinal product name
    Sovaldi
    Investigational medicinal product code
    EU/1/13/894/001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One per day for 8 weeks (Genotype 3 HCV infection only)

    Number of subjects in period 1 [1]
    		Daily observed therapy Fortnightly Pick-up Fortnightly Pick-up with Psych intervention
    Started
    39
    42
    47
    Completed
    33
    37
    40
    Not completed
    6
    5
    7
         Adverse event, serious fatal
    1
    1
    1
         Consent withdrawn by subject
    3
    3
    4
         Protocol deviation
    2
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 135 participants were consented to take part in the trial. 129 were randomised because 6 participants opted not to take part after consent. One individual who was randomised was ineligible and so not part of the analysis.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Daily observed therapy
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up with Psych intervention
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of n

    Reporting group values
    		 Daily observed therapy Fortnightly Pick-up Fortnightly Pick-up with Psych intervention Total
    Number of subjects
    		 39 42 47 128
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.2 ± 8.20 35.7 ± 7.33 37.7 ± 7.53 -
    Gender categorical
    Units: Subjects
        Female
    		 10 11 15 36
        Male
    		 29 31 32 92
    Drug injecting history
    Participants asked whether they last injected illicit drugs during the last week, last month or last 3 months
    Units: Subjects
        Injected within last week
    		 27 28 33 88
        Injected within last month
    		 4 8 6 18
        Injected within last 3 months
    		 8 6 8 22

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Daily observed therapy
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up with Psych intervention
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of n

    Primary: Comparison of Sustained Viral Response at 12 Weeks Post Treatment (SVR12) in the Three Treatment Groups

    		 Close Top of page
    End point title
    		 Comparison of Sustained Viral Response at 12 Weeks Post Treatment (SVR12) in the Three Treatment Groups
    End point description
    SVR12 was measured by PCR test to measure viral load of hepatitis c virus (HCV) in participant's blood at least 12 weeks after end of treatment. A viral load of less than 10IU/ml indicates no active infection and SVR12 has been achieved.
    End point type
    Primary
    End point timeframe
    Measured at 12 weeks post end of treatment
    End point values
    		 Daily observed therapy Fortnightly Pick-up Fortnightly Pick-up with Psych intervention
    Number of subjects analysed
    33
    37
    40
    Units: Participants
        Positive for virus
    3
    5
    3
        Negative for virus
    30
    32
    37
    Statistical analysis title
    		 Non-inferiority
    Comparison groups
    Daily observed therapy v Fortnightly Pick-up
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.67
    Method
    		 logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 3
    Notes
    [1] - Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group
    Statistical analysis title
    		 Non-inferiority
    Comparison groups
    Fortnightly Pick-up v Fortnightly Pick-up with Psych intervention
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.41
    Method
    		 logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 2.45
    Notes
    [2] - Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group
    Statistical analysis title
    		 Non-inferiority
    Comparison groups
    Daily observed therapy v Fortnightly Pick-up with Psych intervention
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.82
    Method
    		 logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 6.61
    Notes
    [3] - Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected for each participant while they were on the trial from consent until final data collection (SVR12). Trial contained active participants for a period of 31 months.
    Adverse event reporting additional description
    Information about adverse events was collected when participants attended the injecting equipment provision sites for injecting equipment and followup. Recorded but not reported as Serious Adverse Events: Death or hospitalisation for assault or accidental injury Hospitalisation for abscesses due to drugs use Hospitalisation for wound management
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Daily observed therapy
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a daily, observed basis by either the nurse or a community pharmacist. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Sofosbuvir Pill: Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection

    Reporting group title
    Fortnightly Pick-up with Psych intervention
    Reporting group description
    		 Patients with active hepatitis C infection genotype 1 will receive 12 weeks treatment with Zepatier at one tablet per day. Patients with active hepatitis C infection genotype 3 will receive 8 weeks treatment with Zepatier pill plus Sofosbuvir pill at one of each tablets per day. These tablets will be given to patients on a fortnightly basis by the nurse. In addition, this group will receive a one-off interview with the researcher to complete a psychological intervention designed to improve adherence to the medication regimen. Zepatier Pill: Drugs will be given to participants to treat hepatitis C infection Psychological intervention: Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, "Hepatitis C and Me". The booklet uses the principles of n

    Serious adverse events
    		 Daily observed therapy Fortnightly Pick-up Fortnightly Pick-up with Psych intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 39 (15.38%)
    9 / 42 (21.43%)
    8 / 47 (17.02%)
         number of deaths (all causes)
    1
    1
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Illicit drug overdose
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 42 (2.38%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Intentional self harm
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 42 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 42 (4.76%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left mild cerebral infarct
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness due to drug use
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Physical assault
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 42 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration pnuemonia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain secondary to fall
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Community acquired pneumonia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abcess
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 42 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic embolus
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 42 (2.38%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 42 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Daily observed therapy Fortnightly Pick-up Fortnightly Pick-up with Psych intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 39 (20.51%)
    10 / 42 (23.81%)
    6 / 47 (12.77%)
    Injury, poisoning and procedural complications
    illicit drug overdose
         subjects affected / exposed
    5 / 39 (12.82%)
    0 / 42 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    5
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 42 (9.52%)
    1 / 47 (2.13%)
         occurrences all number
    1
    4
    1
    Reproductive system and breast disorders
    menorrhagia
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 42 (7.14%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    0
    Infections and infestations
    Injection site infection/abscess
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 42 (7.14%)
    3 / 47 (6.38%)
         occurrences all number
    2
    4
    9

    More information

    		 Close Top of page

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

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31399460
    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.

    European Medicines Agency © 1995-Sat Apr 27 23:50:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA