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   43866   clinical trials with a EudraCT protocol, of which   7287   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 Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks with Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects with Chronic Genotype 1 HCV Infection

    Summary
    EudraCT number
    		 2013-002296-17
    Trial protocol
    		 FR  
    Global end of trial date
    12 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2016
    First version publication date
    19 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-337-0121
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01965535
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    12 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to determine the antiviral efficacy of combination treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 24 weeks and LDV/SOF + ribavirin (RBV) for 12 weeks as measured by the proportion of subjects with sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12), and to evaluate the safety and tolerability of each regimen as assessed by review of the accumulated safety data.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 155
    Worldwide total number of subjects
    155
    EEA total number of subjects
    155
    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)
    123
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled study sites in France. The first participant was screened on 26 September 2013. The last study visit occurred on 12 November 2014.

    Pre-assignment
    Screening details
    		 172 participants were screened.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LDV/SOF 24 Weeks
    Arm description
    		 LDV/SOF plus placebo to match RBV in a divided daily dose for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet once daily

    Investigational medicinal product name
    Placebo to match RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match RBV administered in a divided daily dose

    Arm title
    		 LDV/SOF+RBV 12 Weeks
    Arm description
    		 Placebo to match LDV/SOF + placebo to match RBV for 12 weeks, followed by LDV/SOF + RBV for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to match LDV/SOF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match LDV/SOF once daily

    Investigational medicinal product name
    Placebo to match RBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match RBV administered in a divided daily dose

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV (200 mg tablets) administered in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg)

    Number of subjects in period 1
    		LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Started
    78
    77
    Completed
    76
    76
    Not completed
    2
    1
         Lack of efficacy
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    LDV/SOF 24 Weeks
    Reporting group description
    		 LDV/SOF plus placebo to match RBV in a divided daily dose for 24 weeks

    Reporting group title
    LDV/SOF+RBV 12 Weeks
    Reporting group description
    		 Placebo to match LDV/SOF + placebo to match RBV for 12 weeks, followed by LDV/SOF + RBV for 12 weeks

    Reporting group values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks Total
    Number of subjects
    		 78 77 155
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57 ( 10.7 ) 56 ( 7.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 56 58 114
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2 4
        Not Hispanic or Latino
    		 76 75 151
    Race
    Units: Subjects
        Black or African American
    		 3 1 4
        White
    		 75 76 151
    HCV Genotype
    Units: Subjects
        Genotype 1 (no confirmed subtype)
    		 1 1 2
        Genotype 1a
    		 50 48 98
        Genotype 1b
    		 27 28 55
    Hepatitic C Virus (HCV) RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.5 ( 0.59 ) 6.5 ( 0.47 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    LDV/SOF 24 Weeks
    Reporting group description
    		 LDV/SOF plus placebo to match RBV in a divided daily dose for 24 weeks

    Reporting group title
    LDV/SOF+RBV 12 Weeks
    Reporting group description
    		 Placebo to match LDV/SOF + placebo to match RBV for 12 weeks, followed by LDV/SOF + RBV for 12 weeks

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    		 Close Top of page
    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug. 1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set. 1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set). Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    End point values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Number of subjects analysed
    77
    77
    Units: percentage of participants
        number (not applicable)
    97.4
    96.1
    Statistical analysis title
    		 Statistical Analysis of SVR12
    Statistical analysis description
    A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.
    Comparison groups
    LDV/SOF 24 Weeks v LDV/SOF+RBV 12 Weeks
    Number of subjects included in analysis
    154
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 8.6
    Notes
    [1] - The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.

    Secondary: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    		 Close Top of page
    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Number of subjects analysed
    77
    77
    Units: percentage of participants
    number (not applicable)
        SVR4
    97.4
    97.4
        SVR24
    97.4
    96.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24

    		 Close Top of page
    End point title
    		 Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8, 12, and 24
    End point values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Number of subjects analysed
    77
    77
    Units: percentage of participants
    number (not applicable)
        Week 1
    7.8
    9.1
        Week 2
    50.6
    59.7
        Week 4
    97.4
    97.4
        Week 8
    98.7
    100
        Week 12
    100
    100
        Week 24
    100
    100
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

    		 Close Top of page
    End point title
    		 Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
    End point description
    Participants in Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 8, and 12
    End point values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Number of subjects analysed
    77
    77
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 1 (LDV/SOF: n = 75; LDV/SOF + RBV: n = 75)
    -4.1 ( 0.558 )
    -4.27 ( 0.547 )
        Week 2 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
    -4.74 ( 0.926 )
    -4.94 ( 0.452 )
        Week 4 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
    -5.1 ( 0.582 )
    -5.19 ( 0.433 )
        Week 8 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
    -5.11 ( 0.597 )
    -5.2 ( 0.448 )
        Week 12 (LDV/SOF: n = 77; LDV/SOF + RBV: n = 77)
    -5.11 ( 0.595 )
    -5.2 ( 0.448 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

    		 Close Top of page
    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure is defined as 1) On-treatment virologic failure: a. Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or b. Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or c. Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or 2) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 LDV/SOF 24 Weeks LDV/SOF+RBV 12 Weeks
    Number of subjects analysed
    77
    77
    Units: percentage of participants
    number (not applicable)
        On-Treatment Virologic Failure
    0
    0
        Virologic Relapse
    2.6
    3.9
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    LDV/SOF
    Reporting group description
    		 LDV/SOF plus placebo to match RBV for 24 weeks

    Reporting group title
    LDV/SOF+RBV
    Reporting group description
    		 Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF+RBV for 12 weeks

    Serious adverse events
    		 LDV/SOF LDV/SOF+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 78 (10.26%)
    4 / 77 (5.19%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Mitral valve disease
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve infection
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LDV/SOF LDV/SOF+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 78 (85.90%)
    72 / 77 (93.51%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 78 (8.97%)
    7 / 77 (9.09%)
         occurrences all number
    7
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    31 / 78 (39.74%)
    21 / 77 (27.27%)
         occurrences all number
    41
    29
    Dizziness
         subjects affected / exposed
    5 / 78 (6.41%)
    1 / 77 (1.30%)
         occurrences all number
    5
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 78 (0.00%)
    4 / 77 (5.19%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    35 / 78 (44.87%)
    45 / 77 (58.44%)
         occurrences all number
    37
    52
    Fatigue
         subjects affected / exposed
    15 / 78 (19.23%)
    7 / 77 (9.09%)
         occurrences all number
    17
    7
    Influenza like illness
         subjects affected / exposed
    5 / 78 (6.41%)
    5 / 77 (6.49%)
         occurrences all number
    5
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 78 (10.26%)
    14 / 77 (18.18%)
         occurrences all number
    8
    15
    Diarrhoea
         subjects affected / exposed
    9 / 78 (11.54%)
    9 / 77 (11.69%)
         occurrences all number
    13
    10
    Abdominal pain upper
         subjects affected / exposed
    7 / 78 (8.97%)
    5 / 77 (6.49%)
         occurrences all number
    7
    8
    Constipation
         subjects affected / exposed
    5 / 78 (6.41%)
    5 / 77 (6.49%)
         occurrences all number
    5
    6
    Abdominal distension
         subjects affected / exposed
    3 / 78 (3.85%)
    4 / 77 (5.19%)
         occurrences all number
    4
    4
    Dyspepsia
         subjects affected / exposed
    3 / 78 (3.85%)
    4 / 77 (5.19%)
         occurrences all number
    3
    5
    Abdominal pain
         subjects affected / exposed
    5 / 78 (6.41%)
    2 / 77 (2.60%)
         occurrences all number
    7
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 78 (3.85%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 78 (14.10%)
    10 / 77 (12.99%)
         occurrences all number
    13
    10
    Dyspnoea
         subjects affected / exposed
    3 / 78 (3.85%)
    9 / 77 (11.69%)
         occurrences all number
    3
    10
    Dyspnoea exertional
         subjects affected / exposed
    2 / 78 (2.56%)
    4 / 77 (5.19%)
         occurrences all number
    2
    5
    Epistaxis
         subjects affected / exposed
    5 / 78 (6.41%)
    1 / 77 (1.30%)
         occurrences all number
    5
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    7 / 78 (8.97%)
    12 / 77 (15.58%)
         occurrences all number
    7
    12
    Dry skin
         subjects affected / exposed
    4 / 78 (5.13%)
    12 / 77 (15.58%)
         occurrences all number
    4
    12
    Rash
         subjects affected / exposed
    2 / 78 (2.56%)
    5 / 77 (6.49%)
         occurrences all number
    2
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    13 / 78 (16.67%)
    17 / 77 (22.08%)
         occurrences all number
    14
    17
    Irritability
         subjects affected / exposed
    9 / 78 (11.54%)
    7 / 77 (9.09%)
         occurrences all number
    9
    7
    Sleep disorder
         subjects affected / exposed
    8 / 78 (10.26%)
    5 / 77 (6.49%)
         occurrences all number
    8
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    9 / 78 (11.54%)
    8 / 77 (10.39%)
         occurrences all number
    10
    8
    Arthralgia
         subjects affected / exposed
    12 / 78 (15.38%)
    6 / 77 (7.79%)
         occurrences all number
    14
    6
    Back pain
         subjects affected / exposed
    11 / 78 (14.10%)
    4 / 77 (5.19%)
         occurrences all number
    13
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    13 / 78 (16.67%)
    4 / 77 (5.19%)
         occurrences all number
    13
    5
    Nasopharyngitis
         subjects affected / exposed
    5 / 78 (6.41%)
    4 / 77 (5.19%)
         occurrences all number
    5
    4
    Rhinitis
         subjects affected / exposed
    2 / 78 (2.56%)
    4 / 77 (5.19%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 78 (6.41%)
    6 / 77 (7.79%)
         occurrences all number
    5
    6
    Vitamin D deficiency
         subjects affected / exposed
    3 / 78 (3.85%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2014
    Clinical assessment of weight was added at every on-treatment study visit and physical examinations were removed from on-treatment study visits at Weeks 1, 2, 4, 8, 13, 14, 16, and 20.

    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.
    There were no limitations affecting the analysis or results.
    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-Tue Apr 30 09:33:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA