Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy and Safety of Factor IX (FIX) Contained in AlphaNine® and its Pharmacokinetic Comparison With BENEFIX®, in Patients With Severe Hereditary Haemophilia B

    Summary
    EudraCT number
    		 2008-002037-67
    Trial protocol
    		 BG  
    Global end of trial date
    15 Oct 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2022
    First version publication date
    25 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IG404/1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grifols Biologicals Inc.
    Sponsor organisation address
    5555 Valley Boulevard, Los Angeles, California, United States, 90032
    Public contact
    Department of Drug Development, Grifols Biologicals Inc, IGregulatory.affairs@grifols.com
    Scientific contact
    Department of Drug Development, Grifols Biologicals Inc, IGregulatory.affairs@grifols.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?
    Yes
    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
    15 Oct 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to determine the efficacy and safety of factor IX (FIX) contained in AlphaNine® and its pharmacokinetic comparison with BeneFIX®.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Aug 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 16
    Country: Number of subjects enrolled
    Poland: 9
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    6
    Adults (18-64 years)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted in Bulgaria and Poland from 16 August 2005 to 15 October 2009.

    Pre-assignment
    Screening details
    		 25 subjects who had previously participated in FIX Grifols study were enrolled and treated with AlphaNine® and BeneFIX® and their pharmacokinetic profiles were compared according to a single-dose, sequential administration of AlphaNine® and BeneFIX® after a 7 to 15-day washout period.

    Period 1
    Period 1 title
    Pharmacokinetic Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 AlphaNine®
    Arm description
    		 Subjects received AlphaNine®, 65-75 international units/kilogram (IU/kg), intravenously (IV) at Week 0 (Pharmacokinetic [PK] 1) and Week 26 (PK2) during the 12 month treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AlphaNine®
    Investigational medicinal product code
    Other name
    Plasma-derived coagulation factor IX
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    65-75 IU/kg, IV at Week 0 and Week 26.

    Number of subjects in period 1
    		AlphaNine®
    Started
    25
    Completed
    25
    Period 2
    Period 2 title
    Pharmacokinetic Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 AlphaNine®
    Arm description
    		 Subjects received AlphaNine®, 65-75 IU/kg, IV at Week 0 (PK 1) and Week 26 (PK2) during the 12 month treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AlphaNine®
    Investigational medicinal product code
    Other name
    Plasma-derived coagulation factor IX
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    65-75 IU/kg, IV at Week 0 and Week 26.

    Number of subjects in period 2
    		AlphaNine®
    Started
    25
    Completed
    25
    Period 3
    Period 3 title
    Pharmacokinetic Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BeneFIX®
    Arm description
    		 Subjects who received AlphaNine® during Pharmacokinetic Periods 1 and 2, also received BeneFIX®, a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg (PK3) after a washout period of 7 days (following the second pharmacokinetic study for the Polish subset of subjects and after the 12-month follow-up for the Bulgarian subset).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    BeneFIX®
    Investigational medicinal product code
    Other name
    Recombinant coagulation factor IX
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    65-75 IU/kg, IV.

    Number of subjects in period 3 [1]
    		BeneFIX®
    Started
    22
    Completed
    22
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: There were three subjects who did not proceed in BeneFIX® Pharmacokinetic Period 3.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pharmacokinetic Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Pharmacokinetic Period 1 Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 25.8 ( 8.68 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 25 25
    Race
    Units: Subjects
        Caucasian
    		 25 25

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    AlphaNine®
    Reporting group description
    		 Subjects received AlphaNine®, 65-75 international units/kilogram (IU/kg), intravenously (IV) at Week 0 (Pharmacokinetic [PK] 1) and Week 26 (PK2) during the 12 month treatment period.
    Reporting group title
    AlphaNine®
    Reporting group description
    		 Subjects received AlphaNine®, 65-75 IU/kg, IV at Week 0 (PK 1) and Week 26 (PK2) during the 12 month treatment period.
    Reporting group title
    BeneFIX®
    Reporting group description
    		 Subjects who received AlphaNine® during Pharmacokinetic Periods 1 and 2, also received BeneFIX®, a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg (PK3) after a washout period of 7 days (following the second pharmacokinetic study for the Polish subset of subjects and after the 12-month follow-up for the Bulgarian subset).

    Subject analysis set title
    AlphaNine® and BeneFIX®
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received AlphaNine®, 65-75 international units/kilogram (IU/kg), intravenously (IV) at Week 0 (Pharmacokinetic [PK] 1) and Week 26 (PK2) during the 12-month treatment period. After a washout period of 7 days (following the second pharmacokinetic study for the Polish subset of subjects and after the 12-month follow-up for the Bulgarian subset), subjects also received BeneFIX®, a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg (PK3). The safety analysis was performed in a combined manner throughout the different periods.

    Primary: Number of Subjects Categorised Based on FIX:C Activity Before and at Different Times After Infusion of FIX Concentrate

    		 Close Top of page
    End point title
    		 Number of Subjects Categorised Based on FIX:C Activity Before and at Different Times After Infusion of FIX Concentrate [1]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint. ‘n’ indicates number analysed are the number of subjects with data available for analysis.
    End point type
    Primary
    End point timeframe
    Weeks 0 and 26, PK-3 (up to approximately 4.2 years)
    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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® BeneFIX®
    Number of subjects analysed
    25
    22
    Units: subjects
        FIX Activity<2% at Baseline (n=25,0)
    23
    0
        FIX Activity ≥2% at Baseline (n=25,0)
    2
    0
        FIX Activity <2% at Week 0 [PK-1] (n=21,0)
    21
    0
        FIX Activity ≥2% at Week 0 [PK-1] (n=21,0)
    0
    0
        FIX Activity <2% at Week 26 [PK-2] (n=25,0)
    23
    0
        FIX Activity ≥2% at Week 26 [PK-2] (n=25,0)
    2
    0
        FIX Activity <2% PK-3 (n=0,21)
    0
    19
        FIX Activity ≥2% at PK-3 (n=0,21)
    0
    2
    No statistical analyses for this end point

    Primary: Consumption of FIX Expressed as Total Dose of FIX Infusions in IU/kg per Infusion Used for Prophylaxis and Minor Bleedings

    		 Close Top of page
    End point title
    		 Consumption of FIX Expressed as Total Dose of FIX Infusions in IU/kg per Infusion Used for Prophylaxis and Minor Bleedings [2]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [2] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: IU/kg per infusion of AlphaNine
    1576890
    No statistical analyses for this end point

    Primary: Consumption of FIX Expressed as Total Number of FIX Infusions Used for Prophylaxis and Minor Bleedings

    		 Close Top of page
    End point title
    		 Consumption of FIX Expressed as Total Number of FIX Infusions Used for Prophylaxis and Minor Bleedings [3]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [3] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: infusions
    889
    No statistical analyses for this end point

    Primary: Percentage of Bleeding Episodes With Achievement of Haemostasis

    		 Close Top of page
    End point title
    		 Percentage of Bleeding Episodes With Achievement of Haemostasis [4]
    End point description
    Rating of the physician regarding achievement of haemostasis in every major bleeding episode was based on selecting one of the following options: 1.Excellent: accurate haemostasis, bleeding is controlled early; 2.Good: bleeding arrest or slight oozing, haemorrhage duration and severity, loss of blood and FIX concentrate requirements are as expected; 3.Moderate: moderate bleeding persists, greater loss of blood than expected, additional doses of FIX concentrate or other haemostatic products are needed more than expected; 4.None: uncontrolled bleeding, or even worsening, excessive blood loss, much higher doses of blood derivative products than expected are required. All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [4] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: percentage of bleeding episodes
    number (not applicable)
        Excellent
    75.9
        Good
    16.4
        Moderate
    6.0
        None
    0.8
        Not Specified
    0.2
    No statistical analyses for this end point

    Primary: Number of Subjects With Requirements of Other Blood Derivative Products

    		 Close Top of page
    End point title
    		 Number of Subjects With Requirements of Other Blood Derivative Products [5]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [5] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Major Bleeding Episodes

    		 Close Top of page
    End point title
    		 Number of Subjects With Major Bleeding Episodes [6]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [6] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Surgical Interventions for Bleeding

    		 Close Top of page
    End point title
    		 Number of Subjects With Surgical Interventions for Bleeding [7]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to Month 12
    Notes
    [7] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine®
    Number of subjects analysed
    25
    Units: subjects
    2
    No statistical analyses for this end point

    Primary: Number of Incidences of Inhibitors to FIX

    		 Close Top of page
    End point title
    		 Number of Incidences of Inhibitors to FIX [8]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.2 years
    Notes
    [8] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® and BeneFIX®
    Number of subjects analysed
    25
    Units: incidences
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Thrombogenic Effects Detected by Relevant Changes in Activation Coagulation Markers

    		 Close Top of page
    End point title
    		 Number of Subjects With Thrombogenic Effects Detected by Relevant Changes in Activation Coagulation Markers [9]
    End point description
    Activation coagulation markers included- D-Dimer, thrombin-antithrombin complex (TAT), and prothrombin fragment 1 and 2 (F1+2). All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint. ‘n’ indicates number analysed are the number of subjects with data available for analysis.
    End point type
    Primary
    End point timeframe
    Weeks 0 and 26, PK-3 (up to approximately 4.2 years)
    Notes
    [9] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® BeneFIX®
    Number of subjects analysed
    25
    22
    Units: subjects
        D-Dimer: PK-1 (n=25,0)
    3
    0
        D-Dimer: PK-2 (n=25,0)
    2
    0
        D-Dimer: PK-3 (n=0,22)
    0
    0
        TAT: PK-1 (n=25,0)
    20
    0
        TAT: PK-2 (n=25,0)
    5
    0
        TAT: PK-3 (n=0,22)
    0
    14
        F1+2: PK-1 (n=25,0)
    13
    0
        F1+2: PK-2 (n=25,0)
    8
    0
        F1+2: PK-3 (n=0,22)
    0
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Relevant Changes in Vital Signs After the Infusions of the Pharmacokinetic Assessments

    		 Close Top of page
    End point title
    		 Number of Subjects With Clinically Relevant Changes in Vital Signs After the Infusions of the Pharmacokinetic Assessments [10]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.2 years
    Notes
    [10] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® and BeneFIX®
    Number of subjects analysed
    25
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Adverse Events (AE)

    		 Close Top of page
    End point title
    		 Number of Subjects With Adverse Events (AE) [11]
    End point description
    All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.2 years
    Notes
    [11] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® and BeneFIX®
    Number of subjects analysed
    25
    Units: subjects
    8
    No statistical analyses for this end point

    Primary: Number of Subjects With New Viral Transmission After Treatment

    		 Close Top of page
    End point title
    		 Number of Subjects With New Viral Transmission After Treatment [12]
    End point description
    Viral transmission was determined for HIV (human immunodeficiency virus) 1-2 Immunoglobulin G (IgG) and hepatitis C virus (HCV) IgG. All subjects treated with AlphaNine® (PK1 and PK2) and BeneFIX® (PK3) were analysed for this endpoint.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.2 years
    Notes
    [12] - 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: Only descriptive statistics was planned to be reported for this endpoint.
    End point values
    		 AlphaNine® and BeneFIX®
    Number of subjects analysed
    25
    Units: subjects
        HIV 1-2 IgG
    0
        HCV IgG
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 4.2 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    AlphaNine® and BeneFIX®
    Reporting group description
    		 Subjects received AlphaNine®, 65-75 international units/kilogram (IU/kg), intravenously (IV) at Week 0 (Pharmacokinetic [PK] 1) and Week 26 (PK2) during the 12-month treatment period. After a washout period of 7 days (following the second pharmacokinetic study for the Polish subset of subjects and after the 12-month follow-up for the Bulgarian subset), subjects also received BeneFIX®, a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg (PK3). The safety analysis was performed in a combined manner throughout the different periods.

    Serious adverse events
    		 AlphaNine® and BeneFIX®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 AlphaNine® and BeneFIX®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 25 (32.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Surgical and medical procedures
    Tooth restoration
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    2 / 25 (8.00%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 25 (12.00%)
         occurrences all number
    5
    Haemarthrosis
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    4 / 25 (16.00%)
         occurrences all number
    5
    Tonsillitis
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.

    European Medicines Agency © 1995-Mon May 06 18:57:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA