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

  1. 10/21/19 10/21/19 -
  2. 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

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Blood products and blood supportive care products
Description

Blood products and blood supportive care products

Alias
UMLS CUI-1
C0456388
UMLS CUI-2
C0018938
Sequence Number
Description

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1]
C2348184
Blood Products, Blood Supportive Care Products
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
If other Blood Product, please specify
Description

Other Blood Product

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0456388
UMLS CUI [1,3]
C2348235
If other Blood Supportive Care Product, please specify
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
Cumulative Quantity or Dose
Description

Cumulative Quantity or Dose

Data type

float

Alias
UMLS CUI [1]
C2986497
Units of blood products/blood supportive care products
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
Start Date and Time
Description

day month year 00:00-23:59

Data type

partialDatetime

Alias
UMLS CUI [1]
C3897500
Stop Date and Time
Description

day month year 00:00-23:59

Data type

partialDatetime

Alias
UMLS CUI [1]
C3899266
Status of treatment blind
Description

Status of treatment blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
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
Date blind broken
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken
Description

Reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
If other reason blind broken, please specify
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

Similar models

Logs and repeats: Blood products and blood supportive care products and status of treatment blind

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])
Item Group
Blood products and blood supportive care products
C0456388 (UMLS CUI-1)
C0018938 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Item
Blood Products, Blood Supportive Care Products
text
C0456388 (UMLS CUI [1])
C0018938 (UMLS CUI [2])
Code List
Blood Products, Blood Supportive Care Products
CL Item
Red Blood Cells (RBC)
CL Item
Platelets (PLTS)
CL Item
Whole Blood (WB)
CL Item
Plasma - FFP (FFP)
CL Item
Factor VIII (FVIII)
CL Item
Cryoprecipitate (CRYOP)
CL Item
White Blood Cells (WBC)
CL Item
Other Blood Product (OTBP)
CL Item
G-CSF (GCSF)
CL Item
Prophylactic G-CSF (GCSFP)
CL Item
Treatment G-CSF (GCSFT)
CL Item
G(M)CSF (GMCSF)
CL Item
Erythropoietin (EPO)
CL Item
Pegfilgrastim (Conjugated G-CSF/Neulasta) (PGSF)
CL Item
Oprelvecin (IL-11) (IL11)
CL Item
Other Blood Supportive Care Product (OTBSC)
Other Blood Product
Item
If other Blood Product, please specify
text
C0205394 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Other Blood Supportive Care Product
Item
If other Blood Supportive Care Product, please specify
text
C0205394 (UMLS CUI [1,1])
C0018938 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Cumulative Quantity or Dose
Item
Cumulative Quantity or Dose
float
C2986497 (UMLS CUI [1])
Item
Units of blood products/blood supportive care products
text
C1519795 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C1519795 (UMLS CUI [2,1])
C0018938 (UMLS CUI [2,2])
Code List
Units of blood products/blood supportive care products
CL Item
Microgram (MCG)
CL Item
Bags (BAGS)
CL Item
Units (UNITS)
CL Item
Cubic Centimeters (CC)
CL Item
Random Donor Unit (RANDOM)
CL Item
Single Donor Unit (SINGLE)
Start Date and Time
Item
Start Date and Time
partialDatetime
C3897500 (UMLS CUI [1])
Stop Date and Time
Item
Stop Date and Time
partialDatetime
C3899266 (UMLS CUI [1])
Item Group
Status of treatment blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (Z)
Other reason blind broken, specification
Item
If other reason blind broken, please specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])

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