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    Clinical Trial Results:
    A prospective, multi-center, open-label, single-arm, Phase 2 study to assess the efficacy and safety of clazosentan in reversing angiographically-confirmed cerebral vasospasm in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH) treated by surgical clipping or endovascular coiling.

    Summary
    EudraCT number
    		 2015-002721-18
    Trial protocol
    		 FI  
    Global end of trial date
    15 May 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Nov 2019
    First version publication date
    23 Jun 2018
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Change of Sponsor

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-054-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02560532
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Idorsia Pharmaceuticals Ltd
    Sponsor organisation address
    Hegenheimermattweg 91, Allschwil, Switzerland, 4123
    Public contact
    clinical trial disclosure desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.com
    Scientific contact
    clinical trial disclosure desk, Idorsia Pharmaceuticals Ltd, clinical-trials-disclosure@idorsia.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
    14 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate whether clazosentan has an early effect in reversing angiographically-confirmed cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling or surgical clipping. The study used a Simon 2-stage design. Stage 1 analysis was planned to be performed on the first 10 evaluable subjects, while stage 2 analysis was planned to be conducted, assuming positive stage 1 analysis, on the first 19 evaluable subjects. Criterion to continue to stage 2 (positive stage 1 analysis) is met if > 2 subjects with successful reversal were observed.
    Protection of trial subjects
    Prior to the start of the study, each study site consulted an Independent Ethics Committee (IEC) or Institutional Review Board (IRB), i.e., a review panel that was responsible for ensuring the protection of the rights, safety, and well being of human subjects involved in a clinical investigation. The sponsor and the investigators ensured that the study was conducted in full compliance with International Council for Harmonisation (ICH)-Good Clinical Practice (GCP) Guidelines, the principles of the “Declaration of Helsinki” and with the laws and regulations of the countries in which the research was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 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
    Finland: 1
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Switzerland: 4
    Worldwide total number of subjects
    14
    EEA total number of subjects
    10
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 11 sites in 3 countries from 21 March 2016 to 2 May 2017.

    Pre-assignment
    Screening details
    		 The study included a screening period of variable duration, starting any time after the aneurysm securing procedure and lasting up to a maximum of 14 days from the occurrence of the aneurysm to enrollment into the study. At the time of study termination, 33 subjects had been screened and 14 subjects enrolled.

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

    Arms
    Arm title
    		 Clazosentan 15 mg/h
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clazosentan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Clazosentan was supplied as a concentrated solution for i.v. administration after dilution. The diluted study drug solution was administered as a continuous i.v. infusion at the dose of 15 mg/h for up to a cumulative maximum of 10 days.

    Number of subjects in period 1
    		Clazosentan 15 mg/h
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 14 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 14 14
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.9 ± 8.58 -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 1 1
    Race
    Units: Subjects
        Black or African American
    		 1 1
        American Indian or Alaska
    		 0 0
        Native
    		 0 0
        Native Hawaiian or Other
    		 0 0
        Pacific Islander
    		 0 0
        Asian
    		 1 1
        White
    		 11 11
        Other
    		 1 1
    World Federation of Neurological Societies grade
    Units: Subjects
        Grade I
    		 7 7
        Grade II
    		 1 1
        Grade III
    		 0 0
        Grade IV
    		 6 6
    Location of aneurysm
    Units: Subjects
        Supraclinoid internal carotid artery segments
    		 3 3
        Middle cerebral artery segments
    		 3 3
        Anterior cerebral artery segments
    		 0 0
        Anterior communicating artery
    		 4 4
        Posterior communicating artery
    		 2 2
        Distal vertebral artery
    		 0 0
        Basilar artery
    		 0 0
        Posterior cerebral artery
    		 0 0
        Other: pica
    		 1 1
        Other: posterior inferior cerebellar artery
    		 1 1
    Securing procedures
    Units: Subjects
        Clip
    		 1 1
        Coil
    		 13 13
    Clot Size
    Units: Subjects
        No visible clot
    		 0 0
        Local thin
    		 0 0
        Local thick
    		 2 2
        Diffuse thin
    		 1 1
        Diffuse thick
    		 11 11
    Mechanical ventilation on the day of enrollment
    Units: Subjects
        Yes
    		 3 3
        No
    		 11 11
    Time elapsed between aneurysm rupture and start of treatment
    Units: Days
        arithmetic mean (standard deviation)
    		 7.6 ± 2.20 -

    End points

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    End points reporting groups
    Reporting group title
    Clazosentan 15 mg/h
    Reporting group description
    		 -

    Subject analysis set title
    Evaluable set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Used for the main analysis of the primary and secondary endpoints and included subjects with: Absence of violation of exclusion criteria related to forbidden medications and procedures. Presence of a DSA evaluable for global cerebral vasospasm at baseline and at 3h / 24 h post-study drug initiation.

    Primary: Successful reversal of global cerebral vasospasm (GV) 3 h post study drug initiation

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    End point title
    		 Successful reversal of global cerebral vasospasm (GV) 3 h post study drug initiation [1]
    End point description
    Successful reversal was defined as an improvement in at least one level of severity on the global vasospasm assessment (i.e., from severe to moderate, mild, or none, or from moderate to mild or none) evaluated on DSA. The presence/absence of vasospasm (vsp) was determined at the level of the following 15 proximal (vertebro basilar, left/right intradural ICA, left/right A1, left/right M1, left/right P1) and distal (left/right A2, left/right P2, left/right M2) brain vessels. The severity of the vsp in each vessel segment was indicated as follows: None: no vsp Mild: up to 1/3 vessel narrowing Moderate: more than 1/3 and up to 2/3 vessel narrowing Severe: more than 2/3 vessel narrowing The severity of global vsp was indicated as follows: No significant vsp: ≤2 segments with mild vsp Mild: >2 segments with mild and/or 1 segment with moderate vsp Moderate: ≥2 segments with moderate and/or 1 segment with severe vsp Severe: ≥2 segments with severe vsp
    End point type
    Primary
    End point timeframe
    3 hours post study-drug initiation
    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: Not applicable.
    End point values
    		 Evaluable set
    Number of subjects analysed
    10
    Units: Subjects
        Subjects with successful reversal of GV
    2
    No statistical analyses for this end point

    Secondary: Successful reversal of global cerebral vasospasm 24 hours (+/– 6 h) post-study drug initiation

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    End point title
    		 Successful reversal of global cerebral vasospasm 24 hours (+/– 6 h) post-study drug initiation
    End point description
    Successful reversal of global cerebral vasospasm was defined as described for the primary endpoint when a baseline DSA and a DSA at 24 h were both available
    End point type
    Secondary
    End point timeframe
    24 hours post-study drug initiation
    End point values
    		 Evaluable set
    Number of subjects analysed
    7
    Units: Subjects
    2
    No statistical analyses for this end point

    Secondary: Maximum change in angiographic cerebral circulation time from baseline to 3 hours

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    End point title
    		 Maximum change in angiographic cerebral circulation time from baseline to 3 hours
    End point description
    The maximum change in CCT from baseline to 3 hours is the largest of the differences between CCTs at baseline and CCTs at 3 hours, and the maximum change in CCT from baseline to 24 hours is the largest of the differences between CCTs at baseline and CCTs at 24 hours. This endpoint has been chosen to take into account changes in diameter of small cerebral vessels, not measurable on angiography
    End point type
    Secondary
    End point timeframe
    From baseline to 3 hours
    End point values
    		 Evaluable set
    Number of subjects analysed
    Units: Seconds
        median (full range (min-max))
    -0.7 (-3.0 to 5.9)
    No statistical analyses for this end point

    Secondary: Maximum change in angiographic cerebral circulation time from baseline to 24 hours

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    End point title
    		 Maximum change in angiographic cerebral circulation time from baseline to 24 hours
    End point description
    The maximum change in CCT from baseline to 3 hours is the largest of the differences between CCTs at baseline and CCTs at 3 hours, and the maximum change in CCT from baseline to 24 hours is the largest of the differences between CCTs at baseline and CCTs at 24 hours. This endpoint has been chosen to take into account changes in diameter of small cerebral vessels, not measurable on angiography
    End point type
    Secondary
    End point timeframe
    From baseline to 24 hours
    End point values
    		 Evaluable set
    Number of subjects analysed
    Units: Seconds
        median (full range (min-max))
    -1.6 (-4.3 to 4.7)
    No statistical analyses for this end point

    Post-hoc: Distribution of responding segments (i.e., score ≥ 2) by location at 3 h and 24 h

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    End point title
    		 Distribution of responding segments (i.e., score ≥ 2) by location at 3 h and 24 h
    End point description
    This endpoint was assessed post-hoc with the objective to better characterize the pharmacodynamic effect of clazosentan on the entire cerebral vasculature, including smaller distal vessel segments and the cerebellar arteries. This evaluation considered a larger number of vessel segments (29) than the primary endpoint evaluation (15 segments). Segments were defined as proximal (ICA, A1, M1, vertebral artery, basilar artery, P1) or distal (A2, A3/A4, M2, M3/M4, P2, P3/P4, anterior inferior cerebellar artery, posterior inferior cerebellar artery, superior cerebellar artery). Each evaluable segment with significant vasospasm on the baseline angiogram was graded at 3 h and 24 h post initiation of clazosentan with a 7-level scoring system ranging from −3 for severe worsening to +3 for improvement back to admission state. A segment with a score ≥ 2 (corresponding to at least a significant improvement) was considered as responding.
    End point type
    Post-hoc
    End point timeframe
    3 and 24 hours post study-drug initiation
    End point values
    		 Clazosentan 15 mg/h
    Number of subjects analysed
    14
    Units: Number of evaluated segments
        Number of evaluated segments at 3 hours
    176
        Number of evaluated segments at 24 hours
    124
    Attachments
    		 Untitled (Filename: Number of evaluated segments.JPG)
    No statistical analyses for this end point

    Post-hoc: Distribution of responding subjects ( ≥ 50% of segments with score ≥ 2) by location and time point

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    End point title
    		 Distribution of responding subjects ( ≥ 50% of segments with score ≥ 2) by location and time point
    End point description
    This endpoint was assessed post-hoc with the objective to better characterize the pharmacodynamic effect of clazosentan on the entire cerebral vasculature, including smaller distal vessel segments and the cerebellar arteries. This evaluation considered a larger number of vessel segments (29) than the primary endpoint evaluation (15 segments). Segments were defined as proximal (ICA, A1, M1, vertebral artery, basilar artery, P1) or distal (A2, A3/A4, M2, M3/M4, P2, P3/P4, anterior inferior cerebellar artery, posterior inferior cerebellar artery, superior cerebellar artery). Each evaluable segment with significant vasospasm on the baseline angiogram was graded at 3 h and 24 h post initiation of clazosentan with a 7-level scoring system ranging from −3 for severe worsening to +3 for improvement back to admission state. A segment with a score ≥ 2 (corresponding to at least a significant improvement) was considered as responding.
    End point type
    Post-hoc
    End point timeframe
    3 and 24 hours post-study drug initiation
    End point values
    		 Clazosentan 15 mg/h
    Number of subjects analysed
    14
    Units: Number of evaluated subjects
        Number of subjects evaluated at 3 hours
    14
        Number of subjects evaluated at 24 hours
    9
    Attachments
    		 Untitled (Filename: Number of evaluated subjects.JPG)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Enter description here
    Adverse event reporting additional description
    Enter description here
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Clazosentan 15mg/h
    Reporting group description
    		 Clazosentan

    Serious adverse events
    		 Clazosentan 15mg/h
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral vasoconstriction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Monoplegia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 14 (7.14%)
         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
    		 Clazosentan 15mg/h
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 14 (85.71%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypoxia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Productive cough
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood magnesium decreased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Ultrasound Doppler abnormal
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cell marker increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Vasoplegia syndrome
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Cardiac disorders
    Coronary artery occlusion
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Cerebral vasoconstriction
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Cognitive disorder
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cerebral infarction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Motor dysfunction
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hemianopia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Eye disorders
    Mydriasis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Rash macular
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Cerebral salt-wasting syndrome
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2
    Dyslipidaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2016
    Summary of most relevant changes: Modified entry criteria: - The CT scan at 24‑48 h post aneurysm-securing procedure was removed since any procedure-related injury would have been detected on the CT scan performed just prior to study enrollment. - The definition of severe hypoxemia was modified from PaO2/FiO2 < 300 to PaO2/FiO2 < 250, which was a more realistic definition of severe hypoxemia. - Upon sponsor approval at site level, a CTA could replace a missing or incomplete DSA, at hospital admission. definition of CCT secondary endpoint and how it was to be derived were made: CCT secondary endpoint definition: - The endpoint was modified from ʻchange in angiographic CCTʼ to ʻmaximum change in angiographic CCTʼ. The recommendation to perform the TCD at 3 h post study drug initiation was waived. Also, it was acceptable to perform the hourly TCD assessments only in the vessel that showed the highest mean flow velocity at baseline

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    15 May 2017
    The study was ended prematurely after the planned stage 1 analysis revealed successful reversal of global cerebral vasospasm, based on the primary endpoint definition, in 2 out of the first 10 evaluable subjects. The protocol-specified statistical criterion to prematurely stop the study due to insufficient efficacy was met. However, the primary endpoint definition of successful reversal only considered the larger cerebral artery segments using a semi-quantitative evaluation. A second review of the angiograms was therefore performed, by two external experts, taking into account the smaller more distal artery segments and the cerebellar arteries, using a quantitative evaluation scale. The post-hoc analysis showed a clearly visible pharmacodynamic effect at 3 h, that was even more pronounced at 24 h, in a significant proportion of segments and subjects, in both large proximal and small distal vessels. This effect was also observed in cases that were judged to be unsuccessful reversals according to the pre-defined primary endpoint definition.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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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