ID
38479
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 blood products and blood supportive care products and status of treatment blind form. It has to be filled in for Logs and repeats.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
Versions (2)
- 10/21/19 10/21/19 -
- 12/5/19 12/5/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
October 21, 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
Logs and repeats: Blood products and blood supportive care products and status of treatment blind
Description
Blood products and blood supportive care products
Alias
- UMLS CUI-1
- C0456388
- UMLS CUI-2
- C0018938
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
If you tick "Other Blood Product" or "Other Blood Supportive Care Product", please specify in the appropriate items.
Data type
text
Alias
- UMLS CUI [1]
- C0456388
- UMLS CUI [2]
- C0018938
Description
Other Blood Product
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0456388
- UMLS CUI [1,3]
- C2348235
Description
Other Blood Supportive Care Product
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0018938
- UMLS CUI [1,3]
- C2348235
Description
Cumulative Quantity or Dose
Data type
float
Alias
- UMLS CUI [1]
- C2986497
Description
Units
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0456388
- UMLS CUI [2,1]
- C1519795
- UMLS CUI [2,2]
- C0018938
Description
day month year 00:00-23:59
Data type
partialDatetime
Alias
- UMLS CUI [1]
- C3897500
Description
day month year 00:00-23:59
Data type
partialDatetime
Alias
- UMLS CUI [1]
- C3899266
Description
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
If yes, complete the Adverse Event form and/or Investigational Product forms as appropriate. Fill in also date and reason of blind broken in the appropriate items.
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Reason blind broken
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
Other reason blind broken, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C3845569
- UMLS CUI [1,4]
- C2348235
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Logs and repeats: Blood products and blood supportive care products and status of treatment blind
C0018938 (UMLS CUI-2)
C0018938 (UMLS CUI [2])
C0456388 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0018938 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0456388 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2,1])
C0018938 (UMLS CUI [2,2])
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])