ID

38507

Descrição

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 ITP Therapy and the Medical/Surgical procedures form. It has to be filled in for repeating form.

Link

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

Palavras-chave

Versões (3)
  1. 23/10/2019 23/10/2019 -
  2. 23/10/2019 23/10/2019 -
  3. 05/12/2019 05/12/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

23 de outubro de 2019

DOI

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Licença

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

Inglês

ITP Therapy, Medical/Surgical procedures

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Prior ITP Therapy
Descrição

Prior ITP Therapy

Alias
UMLS CUI-1
C1514463
UMLS CUI-2
C0398650
Sequence Number
Descrição

In the original form this item is hidden.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Drug Name
Descrição

(Trade Name preferred)

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0398650
UMLS CUI [1,3]
C2826302
GSK Drug synonym
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0871468
GSK Drug Collection code
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1516698
UMLS CUI [1,4]
C0805701
Failed coding
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Regimen Sequence
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348184
Unit Dose of medication
Descrição

Unit Dose

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0869039
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Units of medication
Descrição

Units

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Frequency of medication
Descrição

Frequency

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3476109
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Route of medication
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Reason for Medication
Descrição

Reason for Medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date of medication
Descrição

day month year

Tipo de dados

partialDate

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Ongoing?
Descrição

If you tick No, please specify the End Date in the following item.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
End Date of medication
Descrição

day month year

Tipo de dados

partialDate

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
ITP Therapy Treatment Type
Descrição

ITP Therapy Treatment Type

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0398650
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332307
If Prior Treatment, Duration of Response
Descrição

Duration of Response

Tipo de dados

integer

Unidades de medida
  • Weeks
Alias
UMLS CUI [1,1]
C0237585
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0398650
Weeks
Medical/Surgical procedures
Descrição

Medical/Surgical procedures

Alias
UMLS CUI-1
C1948041
Sequence Number
Descrição

In the original form this item is hidden.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1948041
Modified term
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C2826302
MedDRA Synonym
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C1140263
MedDRA lower level term code
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C3898442
Failed coding
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Specific Procedure
Descrição

Specific Procedure

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1948041
UMLS CUI [1,2]
C2348235
Date of Procedure
Descrição

day month year

Tipo de dados

partialDate

Alias
UMLS CUI [1]
C2584899
Stop Date of Procedure
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1948041
Procedure classification code
Descrição

In the original form this item is hidden.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1550373
UMLS CUI [1,2]
C0008902
Were any abnormal bleeding problems encountered during the medical procedure associated with thrombocytopenia ?
Descrição

If you tick yes, please provide details on the AE or SAE forms

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C1948041
UMLS CUI [1,5]
C0332281
UMLS CUI [1,6]
C0040034
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Similar models

ITP Therapy, Medical/Surgical procedures

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Prior ITP Therapy
C1514463 (UMLS CUI-1)
C0398650 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
Modified reported term
text
C1514463 (UMLS CUI [1,1])
C0398650 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
GSK Drug synonym
Item
GSK Drug synonym
text
C0008976 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
GSK Drug Collection code
Item
GSK Drug Collection code
text
C0008976 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Regimen Sequence
Item
Regimen Sequence
text
C1276413 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Unit Dose
Item
Unit Dose of medication
text
C0869039 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Item
Units of medication
text
C1519795 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Units
Code List
Units of medication
CL Item
Gram (G)
CL Item
International units per kilogram (IU/KG)
CL Item
Microgram (MCG) (MCG)
CL Item
Microgram (UG) (UG)
CL Item
Microgram/kilogram (MCG/KG)
CL Item
Micrograms per minute (MCG/MIN)
CL Item
Milligram (MG)
CL Item
Milligram/kilogram (MG/KG)
CL Item
Milligram/metre squared (MG/M2)
CL Item
Unknown (UNK)
CL Item
Units (U)
Item
Frequency of medication
text
C3476109 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Units
Code List
Frequency of medication
CL Item
Unknown (UNK)
CL Item
2 times per week  (2XWK)
CL Item
3 times per week  (3XWK)
CL Item
4 times per week  (4XWK)
CL Item
5 times per day  (5XD)
CL Item
5 times per week  (5XWK)
CL Item
AC (AC)
CL Item
BID  (BID)
CL Item
HS (HS)
CL Item
Once daily (OD)
CL Item
Once only (ONE)
CL Item
PC (PC)
CL Item
PRN (PRN)
CL Item
Q12H (Q12H)
CL Item
Every 2 weeks (Q2WK)
CL Item
Q3D (Q3D)
CL Item
Every 3 months (Q3M)
CL Item
Every 3 weeks (Q3WK)
CL Item
Q4D (Q4D)
CL Item
Q4H (Q4H)
CL Item
Q6H (Q6H)
CL Item
Q8H (Q8H)
CL Item
QAM (QAM)
CL Item
QID (QID)
CL Item
Once a month (QM)
CL Item
Every other day (QOD)
CL Item
QPM (QPM)
CL Item
Once a week (QWK)
CL Item
TID (TID)
Item
Route of medication
text
C0013153 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Units
Code List
Route of medication
CL Item
Unknown (UNK)
CL Item
Injection (INJ)
CL Item
Intravenous (IV)
CL Item
Other (OTH)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date of medication
partialDate
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Ongoing?
text
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication ongoing
Code List
Ongoing?
CL Item
Yes (Y)
CL Item
No (N)
End Date
Item
End Date of medication
partialDate
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
ITP Therapy Treatment Type
integer
C0398650 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
ITP Therapy Treatment Type
Code List
ITP Therapy Treatment Type
CL Item
Prior Treatment (1)
CL Item
During Study (2)
Duration of Response
Item
If Prior Treatment, Duration of Response
integer
C0237585 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
Item Group
Medical/Surgical procedures
C1948041 (UMLS CUI-1)
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
Modified term
Item
Modified term
text
C1948041 (UMLS CUI [1,1])
C2826302 (UMLS CUI [1,2])
MedDRA Synonym
Item
MedDRA Synonym
text
C1948041 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C1948041 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Specific Procedure
Item
Specific Procedure
text
C1948041 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of Procedure
Item
Date of Procedure
partialDate
C2584899 (UMLS CUI [1])
Stop Date of Procedure
Item
Stop Date of Procedure
date
C0806020 (UMLS CUI [1,1])
C1948041 (UMLS CUI [1,2])
Procedure classification code
Item
Procedure classification code
text
C1550373 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
Item
Were any abnormal bleeding problems encountered during the medical procedure associated with thrombocytopenia ?
text
C0205161 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948041 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,5])
C0040034 (UMLS CUI [1,6])
Abnormal bleeding problems
Code List
Were any abnormal bleeding problems encountered during the medical procedure associated with thrombocytopenia ?
CL Item
No (N)
CL Item
Yes (Y)
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