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    Clinical Trial Results:
    A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome.

    Summary
    EudraCT number
    2008-002195-10
    Trial protocol
    NL  
    Global end of trial date
    21 Dec 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    04 May 2023
    First version publication date
    04 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HO89
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, hovon@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, hovon@erasmusmc.nl
    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
    06 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the efficacy of lenalidomide (Revlimid) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormon)/G-CSF (Neupogen) in terms of hematological improvement (HI) as defined by the modified response criteria of the IWG for MDS.
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 May 2009
    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
    Netherlands: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    56
    From 65 to 84 years
    141
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A
    Arm description
    Treatment with lenalidomide monotherapy. The dosing regimen for lenalidomide (Revlimid) is 10 mg once daily, orally on days 1-21 every 28 days. If no HI according to the modified IWG response criteria for MDS is obtained after 6 cycles, the patient will go off protocol treatment. If HI is reached the patient will continue treatment till disease progression or baseline transfusion requirements.
    Arm type
    Active comparator

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide: 10 mg once daily, orally on days 1-21 every 28 days. Treatment -if HI is reached- till disease progression or baseline transfusion requirements.

    Arm title
    Arm B
    Arm description
    Treatment with lenalidomide will be given for 4 cycles. If no HI is obtained Epo (NeoRecormon; 30000 IU weekly) will be added during 2 additional cycles. The dose of Epo (NeoRecormonTM) can be increased to 60000 IU weekly (during cycle 7 & 8). If no HI has been reached G-CSF (Neupogen) will be added at cycle 9-12. If no HI according to the modified IWG response criteria for MDS is obtained after these 12 cycles, the patient will go off protocol treatment. If HI is reached the patient will continue treatment till disease progression or baseline transfusion requirements.
    Arm type
    Experimental

    Investigational medicinal product name
    Lenalidomide (Revlimid)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide 10 mg/day p.o.; day 1-21 during cycle 1-12 / 13 --> maintenance until disease progression or baseline transfusion requirements. Depending on achievement of HI the following will be given if necessary: Epo (NeoRecormon) and G-CSF (Neupogen)

    Investigational medicinal product name
    EPO (NeoRecormon)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Epo (NeoRecormon) 30000 IU/day s.c.; 1x/wk during cycle 5 and 6 (if no HI was reached during cycle 1-4 with Lenalidomide) Epo (NeoRecormon) 60000 IU/day s.c.; 1x/wk during cycle 7 -12 / 13 --> maintenance (if no-HI was reached with the 30000 IU dosage)

    Investigational medicinal product name
    G-CSF (Neupogen)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    G-CSF (Neupogen) (≤ 75kg) 300 μg/day s.c. ; 3x/wk during cycle 9 - 12 / 13 --> maintenance (If no HI was reached on Lenalidomide + EPO) G-CSF (Neupogen) (> 75kg) 480 μg/day s.c. ; 3x/wk during cycle 9 - 12 / 13 --> maintenance (if no HI was reached on Lenalidomide + EPO)

    Number of subjects in period 1
    Arm A Arm B
    Started
    100
    100
    Completed
    0
    0
    Not completed
    100
    100
         Other
    24
    26
         Adverse Reactions
    13
    26
         Lack of efficacy
    63
    48

    Baseline characteristics

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

    Reporting group values
    Overall period Total
    Number of subjects
    200 200
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    56 56
        From 65-84 years
    141 141
        85 years and over
    3 3
    Age continuous
    Units: years
        median (full range (min-max))
    71 (38 to 89) -
    Gender categorical
    Units: Subjects
        Female
    86 86
        Male
    114 114

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    Treatment with lenalidomide monotherapy. The dosing regimen for lenalidomide (Revlimid) is 10 mg once daily, orally on days 1-21 every 28 days. If no HI according to the modified IWG response criteria for MDS is obtained after 6 cycles, the patient will go off protocol treatment. If HI is reached the patient will continue treatment till disease progression or baseline transfusion requirements.

    Reporting group title
    Arm B
    Reporting group description
    Treatment with lenalidomide will be given for 4 cycles. If no HI is obtained Epo (NeoRecormon; 30000 IU weekly) will be added during 2 additional cycles. The dose of Epo (NeoRecormonTM) can be increased to 60000 IU weekly (during cycle 7 & 8). If no HI has been reached G-CSF (Neupogen) will be added at cycle 9-12. If no HI according to the modified IWG response criteria for MDS is obtained after these 12 cycles, the patient will go off protocol treatment. If HI is reached the patient will continue treatment till disease progression or baseline transfusion requirements.

    Primary: Primary endpoint

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    End point title
    Primary endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    See Publication
    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: Statistical analysis has been uploaded in the chart section.
    End point values
    Arm A Arm B
    Number of subjects analysed
    96
    95
    Units: Whole
    96
    95
    Attachments
    List of reported SAE's
    List of reported non-SAE's
    Publication HO89
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs of CTCAE grade 2 or higher, with the exception of alopecia, nausea/vomiting and progression of the disease under study, have to be reported on the Adverse Events CRF.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    -

    Reporting group title
    Arm B
    Reporting group description
    -

    Serious adverse events
    Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 96 (44.79%)
    56 / 95 (58.95%)
         number of deaths (all causes)
    63
    69
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm benign, malignant and unspecif. (inc. cysts/polyp)
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    13 / 96 (13.54%)
    11 / 95 (11.58%)
         occurrences causally related to treatment / all
    12 / 15
    9 / 13
         deaths causally related to treatment / all
    3 / 3
    2 / 3
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    4 / 95 (4.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    5 / 96 (5.21%)
    12 / 95 (12.63%)
         occurrences causally related to treatment / all
    2 / 5
    5 / 14
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    5 / 95 (5.26%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigations
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (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
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    6 / 96 (6.25%)
    11 / 95 (11.58%)
         occurrences causally related to treatment / all
    1 / 7
    3 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Nervous system disorders
    Nervous system disorder
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    5 / 95 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    6 / 96 (6.25%)
    8 / 95 (8.42%)
         occurrences causally related to treatment / all
    5 / 7
    7 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    5 / 96 (5.21%)
    3 / 95 (3.16%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    3 / 96 (3.13%)
    3 / 95 (3.16%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 95 (3.16%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    3 / 96 (3.13%)
    2 / 95 (2.11%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    12 / 96 (12.50%)
    20 / 95 (21.05%)
         occurrences causally related to treatment / all
    10 / 16
    16 / 20
         deaths causally related to treatment / all
    1 / 1
    2 / 4
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 96 (90.63%)
    88 / 95 (92.63%)
    Vascular disorders
    Vascular
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    4 / 96 (4.17%)
    2 / 95 (2.11%)
         occurrences all number
    5
    2
    Surgical and medical procedures
    Surgery/intra-operative injury
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Constitutional symptoms
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    33 / 96 (34.38%)
    32 / 95 (33.68%)
         occurrences all number
    44
    43
    Pain
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    18 / 96 (18.75%)
    11 / 95 (11.58%)
         occurrences all number
    25
    16
    Syndromes
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 95 (1.05%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergy/immunology
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 95 (2.11%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Sexual/reproductive function
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 95 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/upper respiratory
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    16 / 96 (16.67%)
    21 / 95 (22.11%)
         occurrences all number
    21
    25
    Cardiac disorders
    Cardiac arrythmia
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    4 / 96 (4.17%)
    7 / 95 (7.37%)
         occurrences all number
    4
    7
    Cardiac general
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    9 / 96 (9.38%)
    5 / 95 (5.26%)
         occurrences all number
    13
    6
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    16 / 96 (16.67%)
    17 / 95 (17.89%)
         occurrences all number
    18
    22
    Blood and lymphatic system disorders
    Blood/bone marrow
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    52 / 96 (54.17%)
    42 / 95 (44.21%)
         occurrences all number
    108
    92
    Coagulation
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 95 (3.16%)
         occurrences all number
    0
    3
    Hemorrhage/bleeding
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 95 (2.11%)
         occurrences all number
    2
    2
    Lymphatics
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    0 / 96 (0.00%)
    7 / 95 (7.37%)
         occurrences all number
    0
    7
    Ear and labyrinth disorders
    Auditory/ear
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 95 (3.16%)
         occurrences all number
    2
    4
    Eye disorders
    Ocular/visual
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    4 / 95 (4.21%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Gastrointestinal
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    35 / 96 (36.46%)
    28 / 95 (29.47%)
         occurrences all number
    59
    41
    Hepatobiliary disorders
    Hepatobiliary/pancreas
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 95 (2.11%)
         occurrences all number
    4
    3
    Skin and subcutaneous tissue disorders
    Dermatology/skin
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    32 / 96 (33.33%)
    24 / 95 (25.26%)
         occurrences all number
    43
    34
    Renal and urinary disorders
    Renal/genitourinary
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    8 / 96 (8.33%)
    5 / 95 (5.26%)
         occurrences all number
    10
    7
    Endocrine disorders
    Endocrine
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 96 (2.08%)
    1 / 95 (1.05%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal/soft tissue
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    12 / 96 (12.50%)
    13 / 95 (13.68%)
         occurrences all number
    14
    15
    Infections and infestations
    Infection
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    21 / 96 (21.88%)
    33 / 95 (34.74%)
         occurrences all number
    45
    55
    Metabolism and nutrition disorders
    Metabolic/laboratory
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    13 / 96 (13.54%)
    19 / 95 (20.00%)
         occurrences all number
    33
    25

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2011
    Administrative update (new statistician); clarification of several sections; the protocol was not changed but the correct use was emphasized. Addition of Second Primary Malignancy reporting was added.
    02 Oct 2014
    §3 End of Recruitment date was adjusted & §9.3.1 Clarification of the dose reduction scheme
    29 Jun 2020
    With protocol amendment 29 JUNE2020 , the study will be stopped and all patients still on maintenance treatment will continue their current maintenance treatment outside the scope of this study. The continued supply of lenalidomide for the patients still on maintenance treatment after study stop is aligned between the sponsor, the principal investigator and Celgene/BMS. §3; §9.1; §9.2 and §9.5.1 are updated with this information.

    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
    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.

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