ID

38783

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 Pharmacogenetic research consent and withdrawal of consent form.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Keywords

  1. 10/24/19 10/24/19 -
  2. 11/4/19 11/4/19 -
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

Pharmacogenetic research consent and withdrawal of consent

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

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
PGx - Pharmacogenetic research consent
Description

PGx - Pharmacogenetic research consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Description

If you tick Yes, please fill in the Date informed consent obtained for PGx-Pharmacogenetic research and if a blood sample has been collected in the following items. If you tick No, please check the reason in the item "No informed consent obtained for PGx, reason".

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for PGx-Pharmacogenetic research
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Description

If you tick Yes, please record the date sample taken in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C2347500
No informed consent obtained for PGx, reason
Description

No informed consent obtained for PGx, reason

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
If other reason for no informed consent obtained, please specify
Description

Other reason for no informed consent obtained

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C2347500
UMLS CUI [1,5]
C1882120
Date of sample taken of PGx
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C2347500
Pharmacogenetic research withdrawal of consent
Description

Pharmacogenetic research withdrawal of consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C2347500
Has subject withdrawn consent for PGx research?
Description

If you tick Yes, please note the date of informed consent withdrawn in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
Date of informed consent withdrawn
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Description

If you tick Yes, please check reason in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
Reason for request for sample destruction
Description

Reason for request for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
If other reason for request for sample destruction, please specify
Description

Other Reason, specification

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1272683
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0178913
UMLS CUI [1,5]
C2348235

Similar models

Pharmacogenetic research consent and withdrawal of consent

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])
C2985720 (UMLS CUI [2])
Item Group
PGx - Pharmacogenetic research consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Code List
Has informed consent been obtained for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
text
C0005834 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Code List
Has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
CL Item
Yes (Y)
CL Item
No (N)
Item
No informed consent obtained for PGx, reason
text
C0566251 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
Code List
No informed consent obtained for PGx, reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other (Z)
Other reason for no informed consent obtained
Item
If other reason for no informed consent obtained, please specify
text
C0205394 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,4])
C1882120 (UMLS CUI [1,5])
Date of sample taken of PGx
Item
Date of sample taken of PGx
date
C1302413 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Item Group
Pharmacogenetic research withdrawal of consent
C1707492 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Code List
Has subject withdrawn consent for PGx research?
CL Item
No (N)
CL Item
Yes (Y)
Date of informed consent withdrawn
Item
Date of informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Has a request been made for sample destruction?
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Code List
Has a request been made for sample destruction?
CL Item
No (N)
CL Item
Yes (Y)
Item
Reason for request for sample destruction
text
C0566251 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
Code List
Reason for request for sample destruction
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Other Reason, specification
Item
If other reason for request for sample destruction, please specify
text
C3840932 (UMLS CUI [1,1])
C1272683 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])

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