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

  1. 11/4/19 11/4/19 -
  2. 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

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/assessment
Description

Day month year Date the subject ended treatment

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Early withdrawal or unscheduled assessment check questions
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
Were haematology lab samples taken?
Description

Haematology lab samples

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0018941
Were chemistry lab samples taken?
Description

Chemistry lab samples

Data type

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0005834
Was a blood smear performed?
Description

Blood smear

Data type

text

Alias
UMLS CUI [1]
C2238079
Were coagulation parameters calculated?
Description

Calculation of coagulation parameters

Data type

text

Alias
UMLS CUI [1,1]
C1441506
UMLS CUI [1,2]
C0005789
Were renal assessments performed?
Description

Renal assessments

Data type

text

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0022885
Was a PK sample taken?
Description

PK sample

Data type

text

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031328
Were vitals signs taken?
Description

Vital signs

Data type

text

Alias
UMLS CUI [1]
C0518766
Were ophthalmic exams done?
Description

If you tick yes, please check which examination has been done in the following item.

Data type

text

Alias
UMLS CUI [1]
C0200149
Ophthalmic exams type
Description

Ophthalmic exams type

Data type

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0200149
Was WHO bleeding scale assessed?
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
Was a quality of life assessment performed?
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
Is subject less than 6 years of age?
Description

Age

Data type

text

Alias
UMLS CUI [1]
C0001779
Investigational product discontinuation
Description

Investigational product discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the investigational product stopped permanently before the scheduled end of the treatment period?
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
Select primary reason the investigational product was stopped
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
Adverse event, subreason
Description

Adverse event, subreason

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0392360
If Investigator discretion is the primary reason the investigational product was stopped, please specify
Description

Investigator discretion, specification

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
If Decision by subject or proxy is the primary reason the investigational product was stopped, please specify
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

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/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit Type
CL Item
End of treatment/Early withdrawal  (1)
CL Item
Unscheduled (2)
Item Group
Early withdrawal or unscheduled assessment check questions
C0220825 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C2349954 (UMLS CUI-4)
Item
Were haematology lab samples taken?
text
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Code List
Were haematology lab samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were chemistry lab samples taken?
text
C0008000 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Code List
Were chemistry lab samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a blood smear performed?
text
C2238079 (UMLS CUI [1])
Code List
Was a blood smear performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were coagulation parameters calculated?
text
C1441506 (UMLS CUI [1,1])
C0005789 (UMLS CUI [1,2])
Code List
Were coagulation parameters calculated?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were renal assessments performed?
text
C0232804 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Code List
Were renal assessments performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a PK sample taken?
text
C1277698 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Code List
Was a PK sample taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were vitals signs taken?
text
C0518766 (UMLS CUI [1])
Code List
Were vitals signs taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were ophthalmic exams done?
text
C0200149 (UMLS CUI [1])
Code List
Were ophthalmic exams done?
CL Item
Yes (Y)
CL Item
No (N)
Item
Ophthalmic exams type
text
C0332307 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Code List
Ophthalmic exams type
CL Item
Complete (C)
CL Item
Lens (L)
Item
Was WHO bleeding scale assessed?
text
C0043237 (UMLS CUI [1,1])
C3251812 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
Code List
Was WHO bleeding scale assessed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was a quality of life assessment performed?
text
C0034380 (UMLS CUI [1])
Code List
Was a quality of life assessment performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is subject less than 6 years of age?
text
C0001779 (UMLS CUI [1])
Code List
Is subject less than 6 years of age?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Investigational product discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Item
Was the investigational product stopped permanently before the scheduled end of the treatment period?
text
C0304229 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Code List
Was the investigational product stopped permanently before the scheduled end of the treatment period?
CL Item
Yes (Y)
CL Item
No (N)
Item
Select primary reason the investigational product was stopped
integer
C0205225 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Code List
Select primary reason the investigational product was stopped
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Subject reached protocol defined stopping criteria (3)
CL Item
Study closed/terminated (4)
CL Item
Lost to Follow-Up (5)
CL Item
Investigator discretion (6)
CL Item
Decision by subject or proxy (7)
Item
Adverse event, subreason
integer
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Adverse event, subreason
CL Item
Pregnancy (1)
CL Item
No subreason (2)
Investigator discretion, specification
Item
If Investigator discretion is the primary reason the investigational product was stopped, please specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Decision by subject or proxy, specification
Item
If Decision by subject or proxy is the primary reason the investigational product was stopped, please specify
text
C2348235 (UMLS CUI [1,1])
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])

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