ID
38787
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 Date of Visit/Assessment form. It has to be filled in for Screening, Day 1, all Visits of all parts and for all visits of follow-up.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
Versions (2)
- 11/4/19 11/4/19 -
- 12/5/19 12/5/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
November 4, 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
Date of Visit/Assessment
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1320303
- UMLS CUI [2]
- C2985720
Description
Only to fill in for screening.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0449719
Description
If you tick yes, please note if subject is less than 6 years of age in the following item. Only to fill in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Data type
text
Alias
- UMLS CUI [1]
- C0281588
Description
Only to fill in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Data type
text
Alias
- UMLS CUI [1]
- C0001779
Description
If you tick yes, please check which exam (complete, lens) has been done in the following item. To fill in for all visits.
Data type
text
Alias
- UMLS CUI [1]
- C0200149
Description
To fill in for all visits.
Data type
text
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0332307
Description
Only to fill in for Screening, Day 1, P1W1-5, P1W7, P2W1-5, P2W7, P1W8-23, P3W8-23 and P3W8-30.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C0022646
- UMLS CUI [1,3]
- C0431080
Description
Only to fill in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518965
- UMLS CUI [1,2]
- C2238079
Description
Only to fill in for P1W1-5, P1W7, P2W1-5, P2W7, P1W8-23, P3W8-23 and P3W8-30.
Data type
text
Alias
- UMLS CUI [1,1]
- C1441506
- UMLS CUI [1,2]
- C0005789
Similar models
Date of Visit/Assessment
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C0449719 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,3])
C2238079 (UMLS CUI [1,2])
C0005789 (UMLS CUI [1,2])