ID

39141

Beschreibung

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 investigational product form. It has to be filled in for Logs and repeats.

Link

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

Stichworte

Versionen (2)
  1. 21.10.19 21.10.19 -
  2. 05.12.19 05.12.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Dezember 2019

DOI

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Lizenz

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

Englisch

Logs and repeats: Investigational product

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Investigational product
Beschreibung

Investigational product

Alias
UMLS CUI-1
C0304229
Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Date Dispensed
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0947323
Total number of sachets/tablets dispensed
Beschreibung

Total number of sachets/tablets dispensed

Datentyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Container number
Beschreibung

Container number

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
Did the subject return the investigational product?
Beschreibung

If you tick yes, please note the date of return and the total number of sachets/tablets returned in the appropriate items. If you tick no, please specify in the appropriate item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0304229
Date of subject return the investigational product
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0011008
Total number of sachets/tablets returned
Beschreibung

Total number of sachets/tablets returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C2699071
UMLS CUI [2,2]
C0039225
No return of investigational product, specification
Beschreibung

No return of investigational product, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C2348235
Investigational Product. Tick if Open-label tablets
Beschreibung

In the original form this item is hidden

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3640652
Tablets dose received
Beschreibung

If subject did not receive tablet but suspension, fill in the item "Suspension dose received". If you tick alternating dose, please specify in the appropriate item.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1514756
If alternating tablets dose, please specify
Beschreibung

Alternating dose

Datentyp

text

Alias
UMLS CUI [1,1]
C0332270
UMLS CUI [1,2]
C0039225
Suspension dose received
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • mg
Alias
UMLS CUI [1,1]
C0038960
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C1514756
mg
Frequency of investigational product
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C0304229
Units of dosage
Beschreibung

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0304229
Route of investigational product
Beschreibung

In the original form this item is hidden.

Datentyp

text

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

In the original form this item is hidden.

Datentyp

text

Alias
UMLS CUI [1,1]
C1705957
UMLS CUI [1,2]
C0304229
Did the subject receive the correct treatment/dose (e.g., treatment which the subject was assigned to) during this dosing interval?
Beschreibung

Note: For Day 1 dosing, please enter Yes If you tick no, please record reason(s) in the following item.

Datentyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1272706
UMLS CUI [2,1]
C2349182
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0178602
UMLS CUI [2,5]
C1272706
If there was no correct treatment/dose during dosage interval, please record reason(s)
Beschreibung

No correct treatment/dose, reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C2349182
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1298908
UMLS CUI [2,3]
C2349182
UMLS CUI [2,4]
C0178602
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Ähnliche Modelle

Logs and repeats: Investigational product

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational product
C0304229 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Date Dispensed
Item
Date Dispensed
date
C0011008 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Total number of sachets/tablets dispensed
Item
Total number of sachets/tablets dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Container number
Item
Container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Did the subject return the investigational product?
text
C0332156 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product return
Code List
Did the subject return the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Date of subject return the investigational product
Item
Date of subject return the investigational product
date
C0332156 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Total number of sachets/tablets returned
Item
Total number of sachets/tablets returned
integer
C2699071 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
No return of investigational product, specification
Item
No return of investigational product, specification
text
C1298908 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Investigational Product open-label
Item
Investigational Product. Tick if Open-label tablets
boolean
C0304229 (UMLS CUI [1,1])
C3640652 (UMLS CUI [1,2])
Item
Tablets dose received
integer
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
0 mg (Dose interruption period) (0)
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)
CL Item
Alternating Dose (7)
Alternating dose
Item
If alternating tablets dose, please specify
text
C0332270 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
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
Frequency of investigational product
text
C0439603 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Frequency
Code List
Frequency of investigational product
CL Item
Every day (QD)
CL Item
Every other day (QOD)
CL Item
Every 3 days (Q3D)
CL Item
Every 4 days (Q4D)
CL Item
Every 5 days (Q5D)
CL Item
Every 6 days (Q6D)
CL Item
Every week (QWK)
CL Item
Twice weekly (2XW)
CL Item
3 times a week (3XW)
CL Item
4 times a week (4XW)
CL Item
5 times a week (5XW)
CL Item
6 times a week (6XW)
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)
Item
Route of investigational product
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Units
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])
Units
Code List
Formulation of investigational product
CL Item
Tablet (TAB)
CL Item
Suspension (SUSP)
Item
Did the subject receive the correct treatment/dose (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C2349182 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C1272706 (UMLS CUI [2,5])
Investigational product return
Code List
Did the subject receive the correct treatment/dose (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No (N)
No correct treatment/dose, reason
Item
If there was no correct treatment/dose during dosage interval, please record reason(s)
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0392360 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C2349182 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
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