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    Clinical Trial Results:
    Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): An Extension Study

    Summary
    EudraCT number
    		 2010-023650-36
    Trial protocol
    		 HU   BE   NL   GB   ES   CZ   PL   DE   IT   SI  
    Global end of trial date
    22 Apr 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Nov 2016
    First version publication date
    30 Jun 2016
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Added the State to the sponsor's address.

    Trial information

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    Trial identification
    Sponsor protocol code
    HT-ANAM-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01395914
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other: ROMANA 3
    Sponsors
    Sponsor organisation name
    Helsinn Therapeutics (US), Inc.
    Sponsor organisation address
    170 Wood Avenue South, 5th Floor, Iselin, NJ, United States, 08830
    Public contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@helsinn.com
    Scientific contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@helsinn.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
    04 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of Anamorelin HCl
    Protection of trial subjects
    The study was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2011
    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
    Poland: 167
    Country: Number of subjects enrolled
    Slovenia: 1
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 55
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    United States: 20
    Country: Number of subjects enrolled
    Belarus: 14
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Serbia: 6
    Country: Number of subjects enrolled
    Ukraine: 97
    Country: Number of subjects enrolled
    Russian Federation: 100
    Country: Number of subjects enrolled
    Australia: 10
    Worldwide total number of subjects
    513
    EEA total number of subjects
    256
    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)
    356
    From 65 to 84 years
    157
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients who completed dosing in either of the original trials of anamorelin HCl in the treatment of NSCLC-C (HT-ANAM-301 or HT-ANAM-302) were able to enroll in this study and continue to receive the study drug to which they were assigned, either anamorelin HCl 100 mg or placebo QD for an additional 12 weeks.

    Pre-assignment
    Screening details
    		 The primary purpose of this extension study was to permit patients who completed dosing in the original 12-week trials to have the option of continuing to receive randomized study drug for an additional 12 weeks, to further evaluate the safety and tolerability of anamorelin HCl.

    Period 1
    Period 1 title
    Extension 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
    		 Anamorelin HCl
    Arm description
    		 Active drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anamorelin HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets

    Number of subjects in period 1
    		Anamorelin HCl Placebo
    Started
    345
    168
    Completed
    273
    131
    Not completed
    72
    37
         Lost to follow-up
    6
    2
         Unrelated to study drug AE
    6
    1
         Study drug-related AE
    1
    -
         Death
    23
    17
         Other
    9
    3
         Withdrawal by patient
    27
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Anamorelin HCl Placebo Total
    Number of subjects
    		 345 168 513
    Age categorical
    Units: Subjects
        ≤ 65 years
    		 236 120 356
        > 65 years
    		 109 48 157
    Gender categorical
    Units: Subjects
        Female
    		 83 43 126
        Male
    		 262 125 387
    Race
    Units: Subjects
        White
    		 344 166 510
        Asian
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Missing
    		 0 1 1
    Geographic region
    Units: Subjects
        North America
    		 19 5 24
        West Europe
    		 135 72 207
        East Europe + Russia
    		 184 88 272
        Australia
    		 7 3 10

    End points

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    End points reporting groups
    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) Population includes all enrolled patients of the extension trial.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population includes all patients who received any extension trial study drug.

    Primary: To evaluate the safety and tolerability of anamorelin HCl

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    End point title
    		 To evaluate the safety and tolerability of anamorelin HCl [1]
    End point description
    End point type
    Primary
    End point timeframe
    Over the 12-week treatment period
    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: The primary purpose of this extension study was to permit patients who completed dosing in the original 12-week trials to have the option of continuing to receiving study drug for an additional 12 weeks to further evaluate the safety and tolerability of anamorelin HCl. Therefore, no formal statistical hypothesis testing or sample size calculation was conducted.
    End point values
    		 Anamorelin HCl Placebo
    Number of subjects analysed
    179
    93
    Units: Percent
    52
    56
    No statistical analyses for this end point

    Secondary: Change in Body Weight

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    End point title
    		 Change in Body Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Change in body weight from baseline of the original trial and baseline of the extension trial to Weeks 4, 8, and 12.
    End point values
    		 Anamorelin HCl Placebo ITT Population
    Number of subjects analysed
    320
    158
    513
    Units: kg
        least squares mean (standard error)
    3.06 ± 0.631
    0.92 ± 0.697
    2.13 ± 0.451
    No statistical analyses for this end point

    Secondary: Change in Handgrip Strength of the Non-Dominant Hand

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    End point title
    		 Change in Handgrip Strength of the Non-Dominant Hand
    End point description
    End point type
    Secondary
    End point timeframe
    Change and percent change in HGS of the non-dominant hand from baseline of the original trial and baseline of the extension trial to Weeks 8 and 12.
    End point values
    		 Anamorelin HCl Placebo ITT Population
    Number of subjects analysed
    287
    141
    513
    Units: kg
        least squares mean (standard error)
    -0.83 ± 0.929
    -0.55 ± 1.036
    -0.28 ± 0.646
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.
    Adverse event reporting additional description
    Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 -

    Reporting group title
    Total: Placebo and Anamorelin HCl
    Reporting group description
    		 TEAEs were defined as AEs with an onset date on or after the first dose date of the extension trial study drug and up to and including 7 days post-last dose date of the extension trial study drug.

    Serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 167 (12.57%)
    44 / 343 (12.83%)
    65 / 510 (12.75%)
         number of deaths (all causes)
    22
    35
    57
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer metastatic
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    7 / 167 (4.19%)
    16 / 343 (4.66%)
    23 / 510 (4.51%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
    0 / 23
         deaths causally related to treatment / all
    0 / 7
    0 / 16
    0 / 23
    Tumour haemorrhage
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Injury, poisoning and procedural complications
    Splenic rupture
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Tracheo-oesophageal fistula
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 343 (0.00%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 343 (0.00%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 167 (0.60%)
    3 / 343 (0.87%)
    4 / 510 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 167 (0.60%)
    1 / 343 (0.29%)
    2 / 510 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 167 (1.20%)
    1 / 343 (0.29%)
    3 / 510 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 167 (0.60%)
    1 / 343 (0.29%)
    2 / 510 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    3 / 167 (1.80%)
    1 / 343 (0.29%)
    4 / 510 (0.78%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
    Oedema peripheral
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Sudden death
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 167 (0.60%)
    1 / 343 (0.29%)
    2 / 510 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Oesophagitis
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 167 (0.60%)
    2 / 343 (0.58%)
    3 / 510 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 167 (0.60%)
    0 / 343 (0.00%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Respiratory failure
         subjects affected / exposed
    1 / 167 (0.60%)
    2 / 343 (0.58%)
    3 / 510 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 167 (0.00%)
    1 / 343 (0.29%)
    1 / 510 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 167 (0.00%)
    4 / 343 (1.17%)
    4 / 510 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 167 (43.11%)
    135 / 343 (39.36%)
    207 / 510 (40.59%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    25 / 167 (14.97%)
    45 / 343 (13.12%)
    70 / 510 (13.73%)
         occurrences all number
    37
    56
    93
    Neutropenia
         subjects affected / exposed
    8 / 167 (4.79%)
    18 / 343 (5.25%)
    26 / 510 (5.10%)
         occurrences all number
    8
    21
    29
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    14 / 167 (8.38%)
    19 / 343 (5.54%)
    33 / 510 (6.47%)
         occurrences all number
    14
    20
    34
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 167 (5.99%)
    12 / 343 (3.50%)
    22 / 510 (4.31%)
         occurrences all number
    10
    13
    23

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2012
    Protocol amendment

    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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