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    Clinical Trial Results:
    An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)

    Summary
    EudraCT number
    2010-018320-10
    Trial protocol
    BE   NL   ES   IT  
    Global end of trial date
    15 Jun 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-066A302
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01470144
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ACTELION Pharmaceuticals Ltd
    Sponsor organisation address
    Gewerbestrasse 16, Allschwil, Switzerland, 4123
    Public contact
    Thomas Pfister, ACTELION Pharmaceuticals Ltd, medinfo_ch@actelion.com
    Scientific contact
    Thomas Pfister, ACTELION Pharmaceuticals Ltd, medinfo_ch@actelion.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
    26 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess safety and tolerability of Epoprostenol for injection in patients with PAH
    Protection of trial subjects
    Prior to the start of the AC-066A302 study, each study site consulted an Independent Ethics Committee (IEC) or Institutional Review Board (IRB). Actelion ensured that each IEC/IRB consulted was adequately constituted to provide assurance of that protection. The protocol and any written material provided to the subject were reviewed and approved by the appropriate IEC or IRB before the study was started. Amendments to the protocol were also reviewed by the appropriate IEC/IRB before their implementation. The investigator ensured that study AC-066A302 was conducted in full compliance with the principles of the ‘Declaration of Helsinki’ and its amendments, and with the laws and regulations of the country in which the clinical research was conducted. Documentary evidence of adequate Good Clinical Practice (GCP) training of the investigator was collected. GCP training was provided to investigators, if required. A written commitment to comply with GCP and the study protocol was obtained from the investigator. The study enrolled patients who had completed AC-066A301 and had not obtained access to commercially available and reimbursed EFI2 at the time of ending participation in AC-066A301. Patients participating in AC-066A301 were male or female and ≥ 18 years of age with PAH who had been treated with Flolan® for at least 12 months and were on a stable dose for at least 3 months prior to enrollment in AC-066A301. The patient population was consistent with the indication approved for Flolan ®. Additional eligibility criteria at enrollment into AC-066A301 were intended to reduce variability due to disease characteristics and co-morbidities. Eligible patients were required to have completed study AC-066A301. Patients for whom continued treatment with EFI2 was no longer considered appropriate were not eligible.
    Background therapy
    Concomitant PAH medications were allowed, except any prostacyclin or prostacyclin analog other than EFI2. Any other concomitant investigational drugs were forbidden.
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Jun 2011
    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
    France: 20
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 8
    Worldwide total number of subjects
    41
    EEA total number of subjects
    33
    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)
    38
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.

    Pre-assignment
    Screening details
    None

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

    Arms
    Arm title
    Treatment
    Arm description
    All patients who received at least one dose of EFI2
    Arm type
    Experimental

    Investigational medicinal product name
    epoprostenol sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    EFI2 was supplied in 10-mL glass vials that contained 0.5 or 1.5 mg epoprostenol sodium as a lyophilized powder. EFI2 was reconstituted and further diluted with either sterile water for injection or 0.9% w/v sodium chloride for injection, to obtain the “ready -to-use solution” for injection. This solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Infusion sets with an in-line 0.22 micron filter were used. During long-term infusion, the dose of EFI2 was to be adjusted under medical supervision according to therapeutic need and tolerability.

    Number of subjects in period 1
    Treatment
    Started
    41
    Completed
    31
    Not completed
    10
         Lung transplant
    6
         Adverse event, serious fatal
    1
         Adverse event, non-fatal
    2
         Patient’s and investigator’s decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    All patients who received at least one dose of EFI2

    Reporting group values
    Treatment Total
    Number of subjects
    41 41
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    38 38
        From 65-84 years
    3 3
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.8 ± 13.9 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    30 30
        Male
    11 11
    Subject analysis sets

    Subject analysis set title
    All treated set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The All treated set consists of all patients who received at least one dose of study drug in study AC-066A302 and is identical to the All treated set reported for AC-066A301.

    Subject analysis sets values
    All treated set
    Number of subjects
    41
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    38
        From 65-84 years
    3
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.8 ± 13.9
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    30
        Male
    11

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    All patients who received at least one dose of EFI2

    Subject analysis set title
    All treated set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The All treated set consists of all patients who received at least one dose of study drug in study AC-066A302 and is identical to the All treated set reported for AC-066A301.

    Primary: Not applicable

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    End point title
    Not applicable [1]
    End point description
    No primary endpoint was defined. This was an exploratory safety study.
    End point type
    Primary
    End point timeframe
    Not applicable
    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 was an exploratory study. No statistical analysis was performed.
    End point values
    Treatment
    Number of subjects analysed
    0 [2]
    Units: Not applicable
    Notes
    [2] - not applicable
    No statistical analyses for this end point

    Other pre-specified: Treatment-emergent adverse events

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    End point title
    Treatment-emergent adverse events
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Up to 24 hours post treatment
    End point values
    Treatment
    Number of subjects analysed
    41
    Units: Number of patients
    41
    No statistical analyses for this end point

    Other pre-specified: Exposure duration

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    End point title
    Exposure duration
    End point description
    Duration of exposure to EFI
    End point type
    Other pre-specified
    End point timeframe
    Study start to end of treatment
    End point values
    Treatment
    Number of subjects analysed
    41
    Units: year
        median (full range (min-max))
    2.44 (0.5 to 4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study start to end of treatment plus 1 day.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    Reporting group 1 description

    Serious adverse events
    Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 41 (85.37%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Shock haemorrhagic
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Transplant evaluation
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Brain natriuretic peptide increased
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Lung transplant
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Medical device change
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Right ventricular failure
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    Angina pectoris
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac flutter
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary arterial hypertension
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Dizziness
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Device dislocation
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Device occlusion
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Device alarm issue
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Device damage
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Catheter site pain
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device breakage
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device connection issue
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infusion site vesicles
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Device leakage
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Device related sepsis
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Device related infection
    Additional description: Not local infection, not sepsis
         subjects affected / exposed
    2 / 41 (4.88%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis moraxella
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter site cellulitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 41 (95.12%)
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    9 / 41 (21.95%)
         occurrences all number
    10
    Cough
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    10
    Epistaxis
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    7
    Oropharyngeal pain
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    6
    Pulmonary arterial hypertension
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 41 (29.27%)
         occurrences all number
    15
    Dizziness
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    8
    Oedema peripheral
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    5
    Pyrexia
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Asthenia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    14
    Nausea
         subjects affected / exposed
    7 / 41 (17.07%)
         occurrences all number
    8
    Abdominal distension
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    5 / 41 (12.20%)
         occurrences all number
    6
    Dyspepsia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    10
    Pain in jaw
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    6
    Arthralgia
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    6 / 41 (14.63%)
         occurrences all number
    11
    Decreased appetite
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 41 (24.39%)
         occurrences all number
    14
    Bronchitis
         subjects affected / exposed
    8 / 41 (19.51%)
         occurrences all number
    14
    Gastroenteritis
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    5
    Catheter site infection
         subjects affected / exposed
    4 / 41 (9.76%)
         occurrences all number
    6
    Sinusitis
         subjects affected / exposed
    3 / 41 (7.32%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2010
    1. A modification to the formulation of the study drug and resulting changes to its stability, availability and its name were described: − Changes in study drug excipients were described. − Instructions for study drug packaging, and preparation, handling and storage of the study drug solution were updated accordingly. − The drug name was changed to Epoprostenol for injection (EFI). − An additional dose strength of 0.5 mg was added. 2. The estimated treatment duration (until commercialization of the new formulation) was updated from 4–16 months to 2 years. 3. An increase in the numbers of participating countries and of patients to be enrolled was described, in line with changes made in study AC-066A301. 4. Changes were made in the core patient information and informed consent form. 5. Some editorial changes were made for clarification and to correct typographical errors. 6. The authors of the protocol and the sponsor’s contact details and signatories were changed.
    15 Jun 2011
    1. The instructions for the handling and storage of the study drug solution were updated, based on data from an additional in-use stability study that showed that the diluted EFI solution could be stored and administered for longer periods of time than previously described. 2. An increase in the number of patients to be enrolled from 25-30 to 40 patients was described, in line with changes made in study AC-066A301. 3. Changes were made in the core patient information and informed consent form. 4. Some editorial changes were made for clarification and to correct typographical errors. 5. The authors of the protocol and the sponsor’s contact details and signatories were changed.
    28 Feb 2012
    1. The instructions for storage and handling of study drug solution were adjusted for consistency with the proposed Summary of Product Characteristics for EFI. 2. Following withdrawal of sitaxentan from the market by its license holder, inclusion criteria and allowed concomitant medications were updated to exclude sitaxentan. 3. The use of an infusion set with an in-line filter was specified in Section 3.3.1 of the protocol, consistent with the proposed Summary of Product Characteristics for EFI. Prior to this Amendment, the use of an in-line filter had been indicated in the list of ancillary supplies (protocol section 3.6.2) only. 4. The planned study duration was revised, with a delay in enrollment anticipated for AC-066A301 and hence AC-066A302. 5. Changes were made in the core patient information and informed consent form. 6. Minor clarifications, including administrative changes and corrections of typographical errors, were made.

    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/24439982
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