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    Clinical Trial Results:
    IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level ≤ 2%) Hemophilia B Who are Planned to Enter BAX 326 Study 250901 to investigate a New Recombinant FIX Concentrate

    Summary
    EudraCT number
    		 2009-016719-39
    Trial protocol
    		 CZ   BG   PL  
    Global end of trial date
    28 Aug 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    050901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, 1221
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxter Innovations GmbH, ClinicalTrialsDisclosure@baxalta.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
    28 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to prospectively document the exposure to IMMUNINE and to monitor FIX inhibitors over a period of approximately 20 – 50 EDs while receiving prophylactic treatment in up to 50 PTPs aged 12 – 64 years and approximately 20 pediatric PTPs up to 11 years of age with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B who were planned to enter BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101, provided all eligibility criteria had been met.
    Protection of trial subjects
    The study was conducted in accordance with the principles set forth in Title 21 of the US Code of Federal Regulations (CFR), parts 50, 54, 56, 312 and 314, International Committee on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP), and applicable local and national regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2010
    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
    Bulgaria: 4
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Romania: 11
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Ukraine: 6
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Chile: 3
    Country: Number of subjects enrolled
    Colombia: 4
    Worldwide total number of subjects
    49
    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)
    2
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled (signed informed consent) from 18 sites in 9 countries.

    Pre-assignment
    Screening details
    		 A total of 57 subjects were enrolled in the study. Of these, 49 (86.0%) subjects were exposed to IMMUNINE, the investigational product.

    Pre-assignment period milestones
    Number of subjects started
    		 57 [1]
    Number of subjects completed
    		 49

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Screen Failure-5; Eligibility criteria changes-1: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 57 subjects were enrolled in the study. Of these, 49 subjects were exposed to IMMUNINE, the investigational product.
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pediatric subjects (<= 11 years)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMMUNINE (pediatric)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    once or twice weekly 20 – 40 IU/kg, or more according to the bleeding pattern

    Arm title
    		 Adolescent/adult subjects (>= 12 years)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMMUNINE (adolescent/adult)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20–40 IU/kg twice weekly

    Number of subjects in period 1
    		Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years)
    Started
    12
    37
    Completed
    12
    35
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Eligibility criteria changed
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pediatric subjects (<= 11 years)
    Reporting group description
    		 -

    Reporting group title
    Adolescent/adult subjects (>= 12 years)
    Reporting group description
    		 -

    Reporting group values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Total
    Number of subjects
    		 12 37 49
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0 36 36
        Adolescents (12-17 years)
    		 0 1 1
        Children (2-11 years)
    		 10 0 10
        Infants and toddlers (28 days-23 months)
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.6 ± 3.73 32.9 ± 11.24 -
    Gender categorical
    Units:
        Female
    		 0 0 0
        Male
    		 12 37 49
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Comprised all subjects who met inclusion and exclusion criteria and received at least one infusion of IP

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    49
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    36
        Adolescents (12-17 years)
    1
        Children (2-11 years)
    10
        Infants and toddlers (28 days-23 months)
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.5 ± 15.13
    Gender categorical
    Units:
        Female
    0
        Male
    49

    End points

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    End points reporting groups
    Reporting group title
    Pediatric subjects (<= 11 years)
    Reporting group description
    		 -

    Reporting group title
    Adolescent/adult subjects (>= 12 years)
    Reporting group description
    		 -

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Comprised all subjects who met inclusion and exclusion criteria and received at least one infusion of IP

    Primary: Number of IMMUNINE infusions administered for each bleeding episode

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    End point title
    		 Number of IMMUNINE infusions administered for each bleeding episode [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    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: Per protocol, descriptive statistics were collected for this endpoint.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of bleeding episodes
        1 infusion
    8
    32
    40
        2 infusions
    4
    13
    17
        3 and more infusions
    0
    4
    4
    No statistical analyses for this end point

    Primary: Number of subjects who developed inhibitory and total binding antibodies to Factor IX (FIX), severe allergic reaction, thrombotic event

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    End point title
    		 Number of subjects who developed inhibitory and total binding antibodies to Factor IX (FIX), severe allergic reaction, thrombotic event [2]
    End point description
    End point type
    Primary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    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: Per protocol, descriptive statistics were collected for this endpoint.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of subjects
        Inhibitory antibody to FIX
    0
    0
    0
        Total binding antibody to FIX
    2
    0
    2
        Treatment related total binding antibody to FIX
    0
    0
    0
        Severe allergic reaction
    0
    0
    0
        Thrombotic event
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Hemostatic efficacy rating of IMMUNINE at resolution of bleeding

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    End point title
    		 Hemostatic efficacy rating of IMMUNINE at resolution of bleeding
    End point description
    Excellent: Full relief of pain and cessation of objective signs of bleeding (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. None: No improvement or condition worsens.
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of treated bleeding episodes
        Excellent
    4
    20
    24
        Good
    7
    27
    34
        Fair
    0
    2
    2
        None
    0
    0
    0
        Not Done
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Annualized Bleeding Rate

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    End point title
    		 Annualized Bleeding Rate
    End point description
    Annualized Bleeding Rate (ABR) in Subjects with 3+ Months of Prophylaxis
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    6
    29
    35
    Units: Annualized Bleeding Rate
        arithmetic mean (standard deviation)
    5.7 ± 7.33
    3.9 ± 7.33
    4.2 ± 7.25
    No statistical analyses for this end point

    Secondary: IMMUNINE exposure days

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    End point title
    		 IMMUNINE exposure days
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of exposure days
        arithmetic mean (standard deviation)
    31 ± 11.92
    40 ± 13.84
    37.8 ± 13.84
    No statistical analyses for this end point

    Secondary: Total weight-adjusted consumption of IMMUNINE

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    End point title
    		 Total weight-adjusted consumption of IMMUNINE
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: IU/kg
        arithmetic mean (standard deviation)
    1200.7 ± 532.37
    1369.9 ± 458.59
    1328.5 ± 477.58
    No statistical analyses for this end point

    Secondary: Number of infusions for prophylaxis per month and year

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    End point title
    		 Number of infusions for prophylaxis per month and year
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of infusions
    arithmetic mean (standard deviation)
        Per Month
    5.5 ± 1.16
    5.6 ± 1.18
    5.6 ± 1.16
        Per Year
    65.6 ± 13.87
    67 ± 14.12
    66.7 ± 13.93
    No statistical analyses for this end point

    Secondary: Number of infusions for bleeding episode treatment per month and year

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    End point title
    		 Number of infusions for bleeding episode treatment per month and year
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    4
    21
    25
    Units: Number of infusions
    arithmetic mean (standard deviation)
        Per Month
    0.8 ± 0.67
    0.7 ± 0.6
    0.7 ± 0.6
        Per Year
    9.2 ± 8.07
    8.2 ± 7.26
    8.3 ± 7.22
    No statistical analyses for this end point

    Secondary: IMMUNINE weight-adjusted consumption for prophylaxis per month and year

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    End point title
    		 IMMUNINE weight-adjusted consumption for prophylaxis per month and year
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: IU/kg
    arithmetic mean (standard deviation)
        Per Month
    205.1 ± 49.72
    173.9 ± 51.32
    181.5 ± 52.2
        Per Year
    2460.7 ± 596.6
    2086.7 ± 615.81
    2178.3 ± 626.41
    No statistical analyses for this end point

    Secondary: IMMUNINE weight-adjusted consumption for bleeding episode treatment per month and year

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    End point title
    		 IMMUNINE weight-adjusted consumption for bleeding episode treatment per month and year
    End point description
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    4
    21
    25
    Units: IU/kg
    arithmetic mean (standard deviation)
        Per Month
    30.6 ± 24.04
    24.7 ± 20.67
    25.6 ± 20.82
        Per Year
    367.3 ± 288.54
    296 ± 248.09
    307.4 ± 249.82
    No statistical analyses for this end point

    Secondary: Incremental recovery over time

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    End point title
    		 Incremental recovery over time
    End point description
    Incremental recovery (IR) was measured at Week 4, Week 12, Week 26, and Termination. Time points for blood sampling for IR were 0-30 minutes prior to infusion and 30 minutes ± 5 minutes post-infusion. Pediatric subjects (<= 11 years) were 4 (Week 4); 2 (Week 12 and Week 26); 0 at Termination. '9999999999' was entered as result for termination since the results cannot be left blank. Adolescent/adult subjects (>= 12 years) were 27 (Week 4); 20 (Week 12); 7 (Week 26); 18 (Termination). Subjects in Full Analysis Set were 31 (Week 4); 22 (Week 12); 9 (Week 26); 18 (Termination).
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    4
    27
    31
    Units: Number
    arithmetic mean (standard deviation)
        Week 4
    0.9 ± 0.12
    1.1 ± 0.27
    1.1 ± 0.26
        Week 12
    0.9 ± 0.21
    1.1 ± 0.26
    1.1 ± 0.25
        Week 26
    0.8 ± 0.16
    1.2 ± 0.22
    1.1 ± 0.26
        Termination
    9999999999 ± 9999999999
    1.1 ± 0.22
    1.1 ± 0.22
    No statistical analyses for this end point

    Secondary: Quality of Life: Annualized Rate of Health Resource Use

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    End point title
    		 Quality of Life: Annualized Rate of Health Resource Use
    End point description
    Subjects were: For days lost from work or school: 11 pediatric subjects, 36 adolescent/adult subjects; 47 subjects in Full Analysis Set. For all other categories: 12 pediatric subjects, 37 adolescent/adult subjects; 49 subjects in Full Analysis Set . Arithmetic mean value for Emergency room visits (for Full Analysis Set and for adolescent/adult subjects) and for Hospitalizations (for Full Analysis Set) was '<0.1'. Since this value could not be entered into the system, '0.1' was entered instead.
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number
    arithmetic mean (standard deviation)
        Days lost from work or school
    1 ± 3.38
    1.7 ± 5.04
    1.6 ± 4.68
        Unscheduled visits to a practitioner
    1.1 ± 1.64
    0.5 ± 1.29
    0.7 ± 1.39
        Emergency room visits
    0 ± 0
    0.1 ± 0.38
    0.1 ± 0.33
        Hospitalizations
    0 ± 0
    0.1 ± 0.44
    0.1 ± 0.39
        Length of hospital stay
    0 ± 0
    0.2 ± 0.91
    0.2 ± 0.79
    No statistical analyses for this end point

    Secondary: Adverse events (AEs) related to investigational product

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    End point title
    		 Adverse events (AEs) related to investigational product
    End point description
    Serious and non-serious AEs included.
    End point type
    Secondary
    End point timeframe
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    End point values
    		 Pediatric subjects (<= 11 years) Adolescent/adult subjects (>= 12 years) Full Analysis Set
    Number of subjects analysed
    12
    37
    49
    Units: Number of related AEs
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first exposure to IMMUNINE until the end of the study, approximately 3-8 months per subject.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Adolescent/adult subjects (equal or greater than 12 years)
    Reporting group description
    		 Reporting group 2 description

    Reporting group title
    Pediatric subjects (equal or lower than 11 years)
    Reporting group description
    		 Reporting group 1 description

    Serious adverse events
    		 Adolescent/adult subjects (equal or greater than 12 years) Pediatric subjects (equal or lower than 11 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 37 (13.51%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Investigations
    Hepatitis b surface antibody positive
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (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
    Clavicle fracture
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adolescent/adult subjects (equal or greater than 12 years) Pediatric subjects (equal or lower than 11 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 37 (13.51%)
    2 / 12 (16.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 37 (10.81%)
    2 / 12 (16.67%)
         occurrences all number
    6
    2

    More information

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    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.

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