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    Clinical Trial Results:
    A Phase 2 Clinical Study of SHP674 in Patients with Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

    Summary
    EudraCT number
    2022-002190-28
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    04 Feb 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Sep 2022
    First version publication date
    14 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SHP674-201/CL1-95014-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04067518
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 Rue Carnot, Suresnes, France, 92284
    Public contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, clinicaltrials@servier.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Feb 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase 1: To assess the safety and tolerability of a single dose of SHP674 in Japanese subjects (dose confirmation) in the tolerability assessment period of Part 1. Phase 2: To assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese subjects.
    Protection of trial subjects
    Subjects provided informed assent or written informed consent. For subjects (young children) who provided informed assent when applicable as per their age, a written informed consent was obtained from a legally acceptable representative/parent.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    0
    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)
    1
    Children (2-11 years)
    19
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were enrolled at 8 investigative sites in Japan from 17 October 2019 to 18 January 2021.

    Pre-assignment
    Screening details
    A total of 28 subjects were enrolled, 3 into Part 1 and 25 into Part 2, of which 26 subjects were treated, 3 in Part 1 and 23 in Part 2.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Part 1: SHP674
    Arm description
    Subjects with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674, 2500 international units per square metre (IU/m^2) (if body surface area [BSA] ≥0.6 m^2) or 82.5 international units per kilogram (IU/kg) (if BSA <0.6 m^2) intravenously (IV) on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    SHP674
    Investigational medicinal product code
    Other name
    Pegaspargase
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    SHP674 administered by 1 to 2 hours of drip infusion, dose determination: if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days.

    Arm title
    Part 2: SHP674
    Arm description
    Subjects with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.
    Arm type
    Experimental

    Investigational medicinal product name
    SHP674
    Investigational medicinal product code
    Other name
    Pegaspargase
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    SHP674 administered by 1 to 2 hours of drip infusion, dose determination: if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days.

    Number of subjects in period 1
    Part 1: SHP674 Part 2: SHP674
    Started
    3
    23
    Safety Analysis Set
    3
    23
    Full Analysis Set
    0 [1]
    23
    Immunogenicity Analysis Set
    3
    22
    Pharmacokinetic Analysis Set
    3
    23
    Completed
    2
    20
    Not completed
    1
    3
         Adverse Events
    1
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Full analysis set (FAS) included all subjects who were enrolled and received SHP674 in Part 2 of the study. Hence this analysis set did not include any subjects in Part 1 arm group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674, 2500 international units per square metre (IU/m^2) (if body surface area [BSA] ≥0.6 m^2) or 82.5 international units per kilogram (IU/kg) (if BSA <0.6 m^2) intravenously (IV) on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

    Reporting group title
    Part 2: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.

    Reporting group values
    Part 1: SHP674 Part 2: SHP674 Total
    Number of subjects
    3 23 26
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10.2 ± 2.63 6.7 ± 4.79 -
    Gender categorical
    Units: Subjects
        Female
    2 11 13
        Male
    1 12 13
    Race
    Units: Subjects
        Asian
    3 23 26

    End points

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    End points reporting groups
    Reporting group title
    Part 1: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the standard risk (SR) or intermediate risk (IR) groups received total 3 doses of SHP674, 2500 international units per square metre (IU/m^2) (if body surface area [BSA] ≥0.6 m^2) or 82.5 international units per kilogram (IU/kg) (if BSA <0.6 m^2) intravenously (IV) on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

    Reporting group title
    Part 2: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.

    Primary: Part 1: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period

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    End point title
    Part 1: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period [1] [2]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a subject after signing informed consent. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product. TEAE is defined as any untoward medical occurrence in a subject who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 (+7) days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first. A related adverse event signifies that there is a reasonable causal relationship between study treatment and an AE. Safety Analysis Set (SAF) included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
    End point type
    Primary
    End point timeframe
    Enrollment up to 5 weeks
    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: No statistical analysis was planned or performed for this end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in the protocol, this end point was analysed only for Part 1.
    End point values
    Part 1: SHP674
    Number of subjects analysed
    3
    Units: percentage of subjects
    number (not applicable)
        TEAEs
    100.0
        SHP-674-Related TEAEs
    100.0
    No statistical analyses for this end point

    Primary: Part 2: Percentage of Subjects Who Achieved a Plasma Asparaginase Activity of ≥0.1 International Units Per Millilitre (IU/mL) 14 Days (336 Hours) After the First Dose of SHP674

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    End point title
    Part 2: Percentage of Subjects Who Achieved a Plasma Asparaginase Activity of ≥0.1 International Units Per Millilitre (IU/mL) 14 Days (336 Hours) After the First Dose of SHP674 [3] [4]
    End point description
    Full Analysis Set (FAS) included all subjects who were enrolled and received SHP674 in Part 2 of the study.
    End point type
    Primary
    End point timeframe
    14 days after the first dose of SHP674
    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: No statistical analysis was planned or performed for this end point.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in the protocol, this end point was analysed only for Part 2.
    End point values
    Part 2: SHP674
    Number of subjects analysed
    23
    Units: percentage of subjects
        number (confidence interval 95%)
    100.0 (85.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs

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    End point title
    Parts 1 and 2: Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a subject after signing informed consent. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product. TEAE is defined as any untoward medical occurrence in a subject who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first. A related TEAE signifies that there is a reasonable causal relationship between study treatment and an AE. SAF included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
    End point type
    Secondary
    End point timeframe
    Parts 1 and 2: Up to 30 days after last dose of study drug (approximately 49 weeks)
    End point values
    Part 1: SHP674 Part 2: SHP674
    Number of subjects analysed
    3
    23
    Units: percentage of subjects
    number (not applicable)
        TEAEs
    100.0
    100.0
        SHP-674-Related TEAEs
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Percentage of Subjects With Anti-Drug (SHP674) Antibody (ADA) and Anti-Polyethylene Glycol (PEG) Antibody

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    End point title
    Parts 1 and 2: Percentage of Subjects With Anti-Drug (SHP674) Antibody (ADA) and Anti-Polyethylene Glycol (PEG) Antibody
    End point description
    Immunogenicity analysis set (IMAS) included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study and had at least one evaluable post-dose sample. If the pre-dose sample was missing it was considered negative.
    End point type
    Secondary
    End point timeframe
    Part 1: Predose and 25 days post dose; Part 2: Predose and 25 days post dose
    End point values
    Part 1: SHP674 Part 2: SHP674
    Number of subjects analysed
    3
    22
    Units: percentage of subjects
    number (not applicable)
        ADA: Pre-dose
    0
    18.2
        ADA: 25 Days Post Dose
    0
    4.5
        Anti-PEG Antibody: Pre-dose
    0
    9.1
        Anti-PEG Antibody: 25 Days Post Dose
    0
    4.5
    No statistical analyses for this end point

    Secondary: Part 1: Percentage of Subjects Who Achieved a Plasma Asparaginase Activity of ≥0.1 IU/mL 14 Days (336 Hours) After the First Dose of SHP674

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    End point title
    Part 1: Percentage of Subjects Who Achieved a Plasma Asparaginase Activity of ≥0.1 IU/mL 14 Days (336 Hours) After the First Dose of SHP674 [5]
    End point description
    SAF included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
    End point type
    Secondary
    End point timeframe
    14 days after the first dose of SHP674
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in the protocol, this end point was analysed only for Part 1.
    End point values
    Part 1: SHP674
    Number of subjects analysed
    3
    Units: percentage of subjects
        number (confidence interval 95%)
    100.0 (29.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Part 2: Percentage of Subjects With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL

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    End point title
    Part 2: Percentage of Subjects With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL [6]
    End point description
    FAS included all subjects who were enrolled and received SHP674 in Part 2 of the study. 'Number analysed (n)' indicates the number of subjects analysed at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As pre-specified in the protocol, this end point was analysed only for Part 2.
    End point values
    Part 2: SHP674
    Number of subjects analysed
    23
    Units: percentage of subjects
    number (confidence interval 95%)
        ≥0.1 IU/mL: Day 1 (pre-dose)
    0.0 (0.0 to 14.8)
        ≥0.1 IU/mL: Day 1 (5 mins post dose) (n=22)
    100.0 (84.6 to 100.0)
        ≥0.1 IU/mL: Day 1 (4 hours post dose)
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 1 (24 hours post dose)
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 2 post dose
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 4 post dose
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 11 post dose
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 14 post dose
    100.0 (85.2 to 100.0)
        ≥0.1 IU/mL: Day 18 post dose (n=22)
    95.5 (77.2 to 99.9)
        ≥0.1 IU/mL: Day 25 post dose (n=22)
    50.0 (28.2 to 71.8)
        <0.1 IU/mL : Day 1 (pre-dose)
    100.0 (85.2 to 100.0)
        <0.1 IU/mL: Day 1 (5 mins post dose) (n=22)
    0.0 (0.0 to 15.4)
        <0.1 IU/mL: Day 1 (4 hours post dose)
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 1 (24 hours post dose)
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 2 post dose
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 4 post dose
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 11 post dose
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 14 post dose
    0.0 (0.0 to 14.8)
        <0.1 IU/mL: Day 18 post dose (n=22)
    4.5 (0.1 to 22.8)
        <0.1 IU/mL: Day 25 post dose (n=22)
    50.0 (28.2 to 71.8)
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Survival Rate at 1 Year After the Start of Study Treatment

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    End point title
    Parts 1 and 2: Survival Rate at 1 Year After the Start of Study Treatment
    End point description
    Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment. SAF included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
    End point type
    Secondary
    End point timeframe
    1 year after the start of study treatment (from first dose up to 12 months)
    End point values
    Part 1: SHP674 Part 2: SHP674
    Number of subjects analysed
    3
    23
    Units: percentage of subjects
        number (not applicable)
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Parts 1 and 2: Event-free Survival Rate at 1 Year After the Start of Study Treatment

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    End point title
    Parts 1 and 2: Event-free Survival Rate at 1 Year After the Start of Study Treatment
    End point description
    Event-free survival rate is defined as percentage of subjects who did not experience any event and survived at 1 year after the start of study treatment. SAF included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study.
    End point type
    Secondary
    End point timeframe
    1 year after the start of study treatment (from first dose up to 12 months)
    End point values
    Part 1: SHP674 Part 2: SHP674
    Number of subjects analysed
    3
    23
    Units: percentage of subjects
        number (not applicable)
    100.0
    100.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Parts 1 and 2: Up to 30 days after last dose of study drug (approximately 49 weeks)
    Adverse event reporting additional description
    SAF included all subjects who had received at least one dose of SHP674 in Part 1 or Part 2 of the study. As planned and pre-specified in protocol, the safety data was analysed for Part 1 and Part 2 of study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Part 1: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 international units per square metre (IU/m^2) (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4) in the 5-week tolerability assessment period, Day 2 of re-induction therapy (conducted twice) in the 36-week treatment period.

    Reporting group title
    Part 2: SHP674
    Reporting group description
    Subjects with ALL who were stratified into the SR or IR groups received total 3 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (SR: IA2/IR: IA4), Day 2 of re-induction therapy (conducted twice) in the 41-week treatment period and who were stratified into the HR group received total 8 doses of SHP674, 2500 IU/m^2 (if BSA ≥0.6 m^2) or 82.5 IU/kg (if BSA <0.6 m^2) IV on Day 12 of Remission induction therapy (IA4), Day 38 of early consolidation therapy, Day 6 of consolidation therapies (HR3, HR2), Day 7 of consolidation therapy (HR1), Day 2 of re-induction therapy (conducted thrice) in the 45-week treatment period.

    Serious adverse events
    Part 1: SHP674 Part 2: SHP674
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    10 / 23 (43.48%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anaphylactic transfusion reaction
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (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
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Part 1: SHP674 Part 2: SHP674
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    23 / 23 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 23 (30.43%)
         occurrences all number
    0
    11
    Flushing
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    12 / 23 (52.17%)
         occurrences all number
    0
    14
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    4
    Catheter site erythema
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Hunger
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 23 (30.43%)
         occurrences all number
    0
    9
    Seasonal allergy
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    2
    2
    Epistaxis
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    6
    Hypoxia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    0 / 3 (0.00%)
    6 / 23 (26.09%)
         occurrences all number
    0
    10
    Discouragement
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    8
    Depressive symptom
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    5
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Depressed mood
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 23 (21.74%)
         occurrences all number
    2
    10
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    13 / 23 (56.52%)
         occurrences all number
    0
    32
    Antithrombin III decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    12 / 23 (52.17%)
         occurrences all number
    9
    32
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    13 / 23 (56.52%)
         occurrences all number
    0
    34
    Blood albumin decreased
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 23 (4.35%)
         occurrences all number
    3
    3
    Blood bilirubin increased
         subjects affected / exposed
    3 / 3 (100.00%)
    9 / 23 (39.13%)
         occurrences all number
    4
    13
    Blood cholesterol increased
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 23 (13.04%)
         occurrences all number
    1
    6
    Blood fibrinogen decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    16 / 23 (69.57%)
         occurrences all number
    7
    42
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 23 (8.70%)
         occurrences all number
    4
    4
    Blood urea increased
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Coagulation test abnormal
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    6
    Fibrin D dimer increased
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Fibrin degradation products increased
         subjects affected / exposed
    3 / 3 (100.00%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    9 / 23 (39.13%)
         occurrences all number
    0
    12
    Liver function test abnormal
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    6 / 23 (26.09%)
         occurrences all number
    0
    14
    Neutrophil count decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 23 (30.43%)
         occurrences all number
    0
    39
    Plasmin inhibitor decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 23 (13.04%)
         occurrences all number
    7
    6
    Plasminogen decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    3 / 23 (13.04%)
         occurrences all number
    7
    7
    Platelet count decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    22 / 23 (95.65%)
         occurrences all number
    10
    67
    Protein total decreased
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Weight decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    White blood cell count decreased
         subjects affected / exposed
    3 / 3 (100.00%)
    21 / 23 (91.30%)
         occurrences all number
    4
    58
    Immunoglobulins decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    5
    Weight increased
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    5
    Amylase increased
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Blood fibrinogen increased
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 23 (17.39%)
         occurrences all number
    5
    5
    Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 23 (21.74%)
         occurrences all number
    0
    10
    Fall
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Procedural headache
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Nervous system disorders
    Cholinergic syndrome
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Dizziness
         subjects affected / exposed
    2 / 3 (66.67%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    11 / 23 (47.83%)
         occurrences all number
    4
    20
    Leukoencephalopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 3 (100.00%)
    21 / 23 (91.30%)
         occurrences all number
    5
    40
    Coagulopathy
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 23 (21.74%)
         occurrences all number
    0
    5
    Febrile neutropenia
         subjects affected / exposed
    2 / 3 (66.67%)
    18 / 23 (78.26%)
         occurrences all number
    3
    36
    Hypoglobulinaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 23 (17.39%)
         occurrences all number
    1
    4
    Eye disorders
    Glaucoma
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 3 (100.00%)
    6 / 23 (26.09%)
         occurrences all number
    6
    7
    Constipation
         subjects affected / exposed
    2 / 3 (66.67%)
    17 / 23 (73.91%)
         occurrences all number
    4
    24
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    10 / 23 (43.48%)
         occurrences all number
    0
    17
    Lip dry
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    14 / 23 (60.87%)
         occurrences all number
    2
    36
    Proctitis
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    7
    Stomatitis
         subjects affected / exposed
    2 / 3 (66.67%)
    13 / 23 (56.52%)
         occurrences all number
    4
    24
    Vomiting
         subjects affected / exposed
    2 / 3 (66.67%)
    19 / 23 (82.61%)
         occurrences all number
    7
    123
    Cheilitis
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Dental caries
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Proctalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Anal erosion
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    4
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    2
    2
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 3 (33.33%)
    9 / 23 (39.13%)
         occurrences all number
    3
    27
    Hepatic steatosis
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 3 (100.00%)
    17 / 23 (73.91%)
         occurrences all number
    3
    17
    Dry skin
         subjects affected / exposed
    3 / 3 (100.00%)
    10 / 23 (43.48%)
         occurrences all number
    4
    13
    Eczema
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 23 (13.04%)
         occurrences all number
    2
    3
    Erythema
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 23 (17.39%)
         occurrences all number
    1
    4
    Rash
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 23 (8.70%)
         occurrences all number
    2
    4
    Dermatitis acneiform
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Eczema asteatotic
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Ingrowing nail
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Miliaria
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Glycosuria
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 23 (21.74%)
         occurrences all number
    1
    10
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    4
    Pain in extremity
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Muscular weakness
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    10 / 23 (43.48%)
         occurrences all number
    0
    13
    Bacteraemia
         subjects affected / exposed
    1 / 3 (33.33%)
    4 / 23 (17.39%)
         occurrences all number
    1
    4
    Device related infection
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 23 (21.74%)
         occurrences all number
    0
    5
    Hyperlipidaemia
         subjects affected / exposed
    3 / 3 (100.00%)
    2 / 23 (8.70%)
         occurrences all number
    5
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    10 / 23 (43.48%)
         occurrences all number
    0
    21
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 23 (17.39%)
         occurrences all number
    0
    6
    Hypoglycaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    5 / 23 (21.74%)
         occurrences all number
    0
    10
    Hypokalaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    3
    Hyponatraemia
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 23 (30.43%)
         occurrences all number
    0
    11
    Hypoproteinaemia
         subjects affected / exposed
    2 / 3 (66.67%)
    8 / 23 (34.78%)
         occurrences all number
    4
    21
    Increased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Decreased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 23 (21.74%)
         occurrences all number
    1
    7
    Central obesity
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 23 (4.35%)
         occurrences all number
    1
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Malnutrition
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Apr 2019
    -The exclusion criteria, definition of intolerable toxicity and informed consent was modified according to the instruction by PMDA. -The description of the planned study period, withdrawal from the study, backbone therapy drugs provided by the sponsor for investigational use, formulation package presentation, points to note and criteria for changes in treatment during the pre treatment Phase and decision to move to part 2 were adjusted.
    20 May 2019
    -Added genetic testing to hematological laboratory parameters. -Updates to foreign product used for backbone therapy. -Description of labeling of drug formulation, treatment schedule for study arms, safety parameters and informed consent form was adjusted. - Added genetic testing to the administration details and study procedures. -Added increased blood sampling volume associated with adding the genetic testing.
    11 Oct 2019
    -Updated study design, timepoints for investigational product administration, observations, and tests to clarify the definition of Day 1 of consolidation therapy for HR. -The description of nonclinical study results was adjusted and corrected. -The description was adjusted for subject withdrawal, treatment discontinuation, criteria for starting re-induction therapy, definition of intolerable toxicity, screening test items, pregnancy test, definition of adverse events, assessment items, assessment of causal relationship with study treatment, emergency safety measures, safety parameters, handling of missing, unused, and abnormal data and immunogenicity analysis set. -Added dose per package of the drug formulation. -Changes to the descriptions of labeling and storage condition of the formulation. - Corrected dispensing, storage, management, and return of investigational product details. -Specified the backbone therapy drugs that were provided as investigational products and adjusted their description. -Added points to note regarding the number of significant figures calculated for the doses of backbone therapy drugs. -Changes to the criteria for changes in treatment with 6-MP and the points to note. -Added points to note and criteria for changes in treatment during interim maintenance therapy (IM). -Added a description about HBV DNA testing and description adjustment. -Added a description about allowances and description adjustment in ECG measurement schedule. -Corrected immunogenicity description.
    22 Jul 2020
    -Clarified the definition of day in drug administration details, study design. -Adjusted description of treatment and dosing schedule, doses of backbone therapy, tolerability assessment, response definition, bone marrow examination, CR evaluation to clarify operations. -Adjusted description of criteria for changes in treatment with each backbone therapy drug, schedule for study procedures, handling of missing, unused and abnormal data and immunogenicity analysis set. -Added new criteria for changes in treatment by symptom. -Added new points to note and criteria for changes in treatment during early consolidation therapy.
    22 Jan 2021
    -Corrected criteria for changes in treatment by symptom. -Changed the description of viral test.

    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
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