0 Evaluaciones
ID

39071

Descripción

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 Phase conclusion form. It just has to be filled in after completion of Week 4 FU.

Link

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

Palabras clave

Versiones (3)
  1. 21/10/19 21/10/19 -
  2. 4/11/19 4/11/19 -
  3. 26/11/19 26/11/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de noviembre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

    Inglés

    Phase conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Phase conclusion
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit/assessment
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    Phase conclusion
    Descripción

    Phase conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0205390
    Did the subject withdraw from the analysis phase of the study?
    Descripción

    If the subject met the definition of a protocol completer Complete 'Did the subject withdraw from the analysis phase of the study?' = 'No' and enter the date the subject completed treatment/Week 4 follow up (depending on amendment status at site at that time). If the subject did not meet the definition of a protocol completer, Complete 'Did the subject withdraw from the analysis phase of the study?' = 'Yes', the date the subject failed to complete (e.g., date study treatment was prematurely and permanently stopped) and enter the reason the subject did not complete

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0936012
    UMLS CUI [1,3]
    C0205390
    Date of phase completion or withdrawal
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1549507
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C2349954
    Primary reason for withdrawal
    Descripción

    If you tick adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Only tick Investigator discretion if none of the other primary reasons are appropriate. If you tick Investigator discretion, please specify in the following item.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    If primary reason for withdrawal is Investigator discretion, please specify
    Descripción

    Subject withdrawal, Investigator discretion

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008961
    UMLS CUI [1,4]
    C0022423
    UMLS CUI [1,5]
    C2348235
    Data entered and accurate
    Descripción

    Attention Study Investigator Please complete the Phase Conclusion form according to the definitions in the instructions above. However, please only **sign** this form after completion of Week 4 FU for all subjects (both pre and post protocol amendment Is all data entered and accurate for all previous visits (including 4 weeks of follow up) and associated log pages? This data may be used for an interim analysis and some or all of this data may be submitted to regulatory authorities. If Yes, then click the Sign button at the bottom of this form to provide Interim data sign-off.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0008961
    Investigators signature
    Descripción

    Investigators signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Monitor, tick or untick this box to require the investigator to re-sign the case book.
    Descripción

    By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state.This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C1521743
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    Similar models

    Phase conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Phase conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    C2985720 (UMLS CUI [2])
    Item Group
    Phase conclusion
    C1707478 (UMLS CUI-1)
    C0205390 (UMLS CUI-2)
    Item
    Did the subject withdraw from the analysis phase of the study?
    text
    C2349954 (UMLS CUI [1,1])
    C0936012 (UMLS CUI [1,2])
    C0205390 (UMLS CUI [1,3])
    Withdraw from analysis phase
    Code List
    Did the subject withdraw from the analysis phase of the study?
    CL Item
    No (N)
    CL Item
    Yes (Y)
    Date of phase completion or withdrawal
    Item
    Date of phase completion or withdrawal
    date
    C1549507 (UMLS CUI [1])
    C0011008 (UMLS CUI [2,1])
    C2349954 (UMLS CUI [2,2])
    Item
    Primary reason for withdrawal
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol deviation (3)
    CL Item
    Subject reached protocol defined stopping criteria (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Investigator discretion (7)
    CL Item
    Withdrew consent (8)
    Subject withdrawal, Investigator discretion
    Item
    If primary reason for withdrawal is Investigator discretion, please specify
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008961 (UMLS CUI [1,3])
    C0022423 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Data entered and accurate
    Item
    Data entered and accurate
    boolean
    C0750484 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    Investigators signature
    Item
    Investigators signature
    text
    C2346576 (UMLS CUI [1])
    Check
    Item
    Monitor, tick or untick this box to require the investigator to re-sign the case book.
    boolean
    C1283174 (UMLS CUI [1,1])
    C1521743 (UMLS CUI [1,2])
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