ID
39145
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 End of treatment/Early withdrawal and unscheduled visit assessments forms as well as information on discontinuation of the investigational product.
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
December 5, 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
End of treatment/Early withdrawal, Unscheduled visit assessments; discontinuation of investigational product
Description
Early withdrawal or unscheduled assessment check questions
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C1279919
- UMLS CUI-4
- C2349954
Description
Haematology lab samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0018941
Description
Chemistry lab samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0005834
Description
Blood smear
Data type
text
Alias
- UMLS CUI [1]
- C2238079
Description
Calculation of coagulation parameters
Data type
text
Alias
- UMLS CUI [1,1]
- C1441506
- UMLS CUI [1,2]
- C0005789
Description
Renal assessments
Data type
text
Alias
- UMLS CUI [1,1]
- C0232804
- UMLS CUI [1,2]
- C0022885
Description
PK sample
Data type
text
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031328
Description
Vital signs
Data type
text
Alias
- UMLS CUI [1]
- C0518766
Description
If you tick yes, please check which examination has been done in the following item.
Data type
text
Alias
- UMLS CUI [1]
- C0200149
Description
Ophthalmic exams type
Data type
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0200149
Description
Assessment of WHO bleeding scale
Data type
text
Alias
- UMLS CUI [1,1]
- C0043237
- UMLS CUI [1,2]
- C3251812
- UMLS CUI [1,3]
- C0681889
Description
If you tick yes, please note if the subject is less than 6 years of age in the following item.
Data type
text
Alias
- UMLS CUI [1]
- C0034380
Description
Age
Data type
text
Alias
- UMLS CUI [1]
- C0001779
Description
Investigational product discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Description
If you tick yes, please complete the primary reason in the following item. Only to fill in for End of treatmen/early withdrawal.
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C2347804
Description
If you tick "Adverse event": Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Additionally check if the adverse event is a matter of pregnancy or if there is no subreason in the appropriate item. Select "Investigator discretion" or "Decision by subject or proxy" if none of the other primary reasons are appropriate. If you do so, please specify in the appropriate items.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0205225
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0444930
- UMLS CUI [1,4]
- C0304229
Description
Adverse event, subreason
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0392360
Description
Investigator discretion, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Description
Decision by subject or proxy, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [1,3]
- C0679006
- UMLS CUI [2,1]
- C2348235
- UMLS CUI [2,2]
- C0422727
- UMLS CUI [2,3]
- C0600420
- UMLS CUI [2,4]
- C0679006
Similar models
End of treatment/Early withdrawal, Unscheduled visit assessments; discontinuation of investigational product
C3854240 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C2349954 (UMLS CUI-4)
C0018941 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0005789 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
C0457454 (UMLS CUI-2)
C0457454 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C0600420 (UMLS CUI [2,3])
C0679006 (UMLS CUI [2,4])