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ID

38411

Description

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the Vital signs form. It has to be filled in for all study visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Keywords

  1. 10/16/19 10/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

    Vital signs

    1. StudyEvent: ODM
      1. Vital signs
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit type
    Description

    If you tick "P1W24/EW", "P3W24/EW" or "P3W31/EW" note in the following item if this is an early withdrawal.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Early withdrawal
    Description

    Early withdrawal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1279919
    UMLS CUI [1,2]
    C2349954
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Body Height
    Description

    Only for Screening and Day 1.

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body weight
    Description

    Only for Screening and Day 1.

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Description

    Only for Screening

    Data type

    float

    Measurement units
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m^2
    Systolic blood pressure
    Description

    Systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Respiration rate
    Description

    Respiration rate

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0231832
    breaths/min

    Similar models

    Vital signs

    1. StudyEvent: ODM
      1. Vital signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit type
    CL Item
    Day 1 (1)
    CL Item
    P1W1 (2)
    CL Item
    P1W2 (3)
    CL Item
    P1W3 (4)
    CL Item
    P1W4 (5)
    CL Item
    P1W5 (6)
    CL Item
    P1W6 (7)
    CL Item
    P1W7 (8)
    CL Item
    P1W8-23 (9)
    CL Item
    P1W24/EW (10)
    CL Item
    P2W1 (11)
    CL Item
    P2W2 (12)
    CL Item
    P2W3 (13)
    CL Item
    P2W4 (14)
    CL Item
    P2W5 (15)
    CL Item
    P2W6 (16)
    CL Item
    P2W7 (17)
    CL Item
    P3W8-23 (18)
    CL Item
    P3W8-30 (19)
    CL Item
    P3W24/EW (20)
    CL Item
    P3W31/EW (21)
    CL Item
    FUW1 (22)
    CL Item
    FUW2 (23)
    CL Item
    FUW3 (24)
    CL Item
    FUW4 (25)
    CL Item
    Screening (0)
    CL Item
    FUM3 (26)
    CL Item
    FUM6 (27)
    Early withdrawal
    Item
    Early withdrawal
    boolean
    C1279919 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Actual date
    Item
    Actual date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Body Height
    Item
    Body Height
    integer
    C0005890 (UMLS CUI [1])
    Body weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Respiration rate
    Item
    Respiration rate
    integer
    C0231832 (UMLS CUI [1])

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