ID

38782

Beskrivning

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 Pharmacokinetics and Investigational products for PK form. It has to be filled in for Part 1 for all weeks (1-24/EW), for Part 2 for all weeks (1-7) and for all weeks of Part 3.

Länk

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

Nyckelord

Versioner (1)
  1. 2019-11-04 2019-11-04 -
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GlaxoSmithKline

Uppladdad den

4 november 2019

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Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

Engelsk

Pharmacokinetics, Investigational products for PK

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beskrivning

If you tick "P1W24/EW", "P3W24/EW" or "P3W31/EW", please tick in the following item if this is an early withdrawal. Note: Only for P1W6, P2W6 and as unscheduled form the Pharmacokinetic serial has to be filled in. For all other visits only the pharmacokinetic has to be filled in.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Early Withdrawal
Beskrivning

Early Withdrawal

Datatyp

boolean

Alias
UMLS CUI [1]
C2349954
Investigational product for PK Sampling
Beskrivning

Investigational product for PK Sampling

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0031328
UMLS CUI-3
C0005834
Dose relative to PK sample
Beskrivning

Please check for which Dose relative to PK sample you'll fill in this itemgroup. Only to fill in for P1W6, P2W6 and for unscheduled.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005834
Investigational Product
Beskrivning

In the original form this item is hidden.

Datatyp

integer

Alias
UMLS CUI [1]
C0304229
Type of Investigational Product
Beskrivning

Type of Investigational Product

Datatyp

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332307
Tablets dose received
Beskrivning

If subject did not receive tablet but suspension, fill in the item "Suspension dose received".

Datatyp

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1514756
Suspension dose received
Beskrivning

If subject did not receive suspension but tablets, fill in the item "Tablets dose received".

Datatyp

integer

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C0038960
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1514756
mg
Units of dosage
Beskrivning

In the original form this item is hidden.

Datatyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0304229
Date dose taken
Beskrivning

Day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0304229
Time dose taken
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0304229
Route of investigational product
Beskrivning

In the original form this item is hidden.

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Formulation of investigational product
Beskrivning

In the original form this item is hidden.

Datatyp

text

Alias
UMLS CUI [1,1]
C1705957
UMLS CUI [1,2]
C0304229
Did the subject vomit?
Beskrivning

Vomit

Datatyp

text

Alias
UMLS CUI [1]
C0042963
Were dairy products consumed within 4 hours of study drug administration?
Beskrivning

In the original form this item is hidden.

Datatyp

text

Alias
UMLS CUI [1,1]
C0010947
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C1533734
Was the required interval (as defined in protocol) between study drug administration and dairy product consumption violated?
Beskrivning

Violation of interval between investigational product and diary product consumption

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1272706
UMLS CUI [1,3]
C0010947
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C1533734
Pharmacokinetics blood
Beskrivning

Pharmacokinetics blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Dosing Date
Beskrivning

Day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Dosing Time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Time relative to dosage
Beskrivning

Only to fill in for P1W6, P2W6 and for unscheduled.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
Actual Date PK sample taken
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
Actual Time PK sample taken
Beskrivning

00:00-23:59

Datatyp

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0040223
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Similar models

Pharmacokinetics, Investigational products for PK

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
P1W1 (1)
CL Item
P1W2 (2)
CL Item
P1W3 (3)
CL Item
P1W4 (4)
CL Item
P1W5 (5)
CL Item
P1W6 (6)
CL Item
P1W7 (7)
CL Item
P1W8-23 (8)
CL Item
P1W24/EW (9)
CL Item
P2W1 (10)
CL Item
P2W2 (11)
CL Item
P2W3 (12)
CL Item
P2W4 (13)
CL Item
P2W5 (14)
CL Item
P2W6 (15)
CL Item
P2W7 (16)
CL Item
P3W8-23 (17)
CL Item
P3W8-30 (18)
CL Item
P3W24/EW (19)
CL Item
P3W31/EW (20)
CL Item
Unscheduled (21)
Early Withdrawal
Item
Early Withdrawal
boolean
C2349954 (UMLS CUI [1])
Item Group
Investigational product for PK Sampling
C0304229 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
Item
Dose relative to PK sample
integer
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
Investigational Product
Code List
Dose relative to PK sample
CL Item
Prior to PK sample (1)
CL Item
Prior to pre-dose PK sample (2)
CL Item
Immediately after the pre-dose PK sample (3)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product
CL Item
Open-label tablets (1)
Item
Type of Investigational Product
integer
C0304229 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Investigational Product
Code List
Type of Investigational Product
CL Item
Tablet (1)
CL Item
Suspension (2)
Item
Tablets dose received
text
C0039225 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Tablets dose received
Code List
Tablets dose received
CL Item
12.5 mg (1)
CL Item
25 mg (2)
CL Item
37.5 mg (3)
CL Item
50 mg (4)
CL Item
62.5 mg (5)
CL Item
75 mg (6)
Suspension dose received
Item
Suspension dose received
integer
C0038960 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514756 (UMLS CUI [1,4])
Item
Units of dosage
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Units
Code List
Units of dosage
CL Item
Milligram (MG)
Date dose taken
Item
Date dose taken
date
C0011008 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Time dose taken
Item
Time dose taken
time
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Route of investigational product
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Route
Code List
Route of investigational product
CL Item
Oral (PO)
Item
Formulation of investigational product
text
C1705957 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Formulation
Code List
Formulation of investigational product
CL Item
Tablet (TAB)
CL Item
Suspension (SUSP)
Item
Did the subject vomit?
text
C0042963 (UMLS CUI [1])
Vomit
Code List
Did the subject vomit?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were dairy products consumed within 4 hours of study drug administration?
text
C0010947 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
Vomit
Code List
Were dairy products consumed within 4 hours of study drug administration?
CL Item
Yes (Y)
CL Item
No (N)
Item
Was the required interval (as defined in protocol) between study drug administration and dairy product consumption violated?
text
C1709750 (UMLS CUI [1,1])
C1272706 (UMLS CUI [1,2])
C0010947 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
Vomit
Code List
Was the required interval (as defined in protocol) between study drug administration and dairy product consumption violated?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Pharmacokinetics blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Dosing Date
Item
Dosing Date
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Dosing Time
Item
Dosing Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time relative to dosage
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Time relative to dosage
Code List
Time relative to dosage
CL Item
Pre-dose (1)
CL Item
2 hrs post-dose (2)
CL Item
4 hrs post-dose (3)
CL Item
6 hrs post-dose (4)
CL Item
8 hrs post-dose (5)
CL Item
24 hrs post-dose (6)
Actual Date PK sample taken
Item
Actual Date PK sample taken
date
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Actual Time PK sample taken
Item
Actual Time PK sample taken
date
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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