ID

38408

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 demography form. It has to be filled in for screening.

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

Demography

  1. StudyEvent: ODM
    1. Demography
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
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
If female, please record the child-bearing potential
Description

Child-bearing potential

Data type

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Description

Ethnicity

Alias
UMLS CUI-1
C0015031
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Description

Geographic ancestry

Alias
UMLS CUI-1
C3841890
African American/African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - White/Caucasian/European Heritage
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0043157

Similar models

Demography

  1. StudyEvent: ODM
    1. Demography
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 Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
If female, please record the child-bearing potential
integer
C3831118 (UMLS CUI [1])
Code List
If female, please record the child-bearing potential
CL Item
Pre-menarcheal (1)
CL Item
Potentially able to bear children (4)
Item Group
Ethnicity
C0015031 (UMLS CUI-1)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Geographic ancestry
C3841890 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White/Caucasian/European Heritage
Item
White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])

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