ID
39148
Descripción
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 liver events form. It has to be filled in if a liver event occurs during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palabras clave
Versiones (2)
- 24/10/19 24/10/19 -
- 5/12/19 5/12/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de diciembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Liver events
- StudyEvent: ODM
Descripción
General Information
Alias
- UMLS CUI-1
- C1508263
Descripción
Item is not required. Please note the date and time of each you've ticked.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302584
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0422202
Descripción
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Descripción
If you tick yes, please complete liver event forms and serious adverse event form immediately.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0023884
Descripción
alanine aminotransferase stop criterion
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria? This item is conditional. Interruption may be removed if stopping/monitoring study only.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Descripción
Age
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001779
Descripción
If you tick yes, ensure Pregnancy Notification Form has been completed.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0032961
Descripción
If you tick yes, please note the results of test in the following item.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C1711359
- UMLS CUI [2,1]
- C0041618
- UMLS CUI [2,2]
- C0023884
- UMLS CUI [3]
- C1275400
- UMLS CUI [4]
- C0024485
- UMLS CUI [5]
- C0008310
Descripción
If no, record the details on the Imaging form. Please ensure the overall diagnosis Indicated by Imaging Is captured on the Non-serious Adverse Event form or Serious Adverse Event form.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Descripción
If you tick yes, complete Liver Biopsy form.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0193388
Descripción
If you tick yes, record on the appropriate Concomitant Medication form.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Descripción
Fast or significant dietary change
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Descripción
Evaluation interval code
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2985767
Descripción
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Descripción
Onset of liver event
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C0023884
Descripción
day month year. If the liver event occurred during/after treatment period record start date of lnvestigatlonal product for that treatment period.
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Descripción
investigational product Start date not applicable
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Descripción
day month year. If the liver event occurred during/after treatment period record end date of lnvestigatlonal product for that treatment period.
Tipo de datos
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Descripción
investigational product end date not applicable
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Descripción
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031328
Descripción
Design notes: An unscheduled PK sample must be obtained within 72 hours of last dose
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0031328
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Descripción
Sample Identifier/Sample Number Pharmacokinetics
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Descripción
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Descripción
Specific Condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Descripción
Tick only one response for each condition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Descripción
Drug related liver disease condition (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Descripción
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Descripción
Item is not required
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
Specific condition
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826302
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3898442
Descripción
Item is not required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descripción
This item is optional
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
- UMLS CUI [1,3]
- C0205394
Descripción
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Descripción
Disease
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0012634
Descripción
Presence of disease
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Descripción
Alcohol intake at onset of liver event (Liver alcohol)
Alias
- UMLS CUI-1
- C0001948
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0332162
- UMLS CUI-4
- C0877248
Descripción
Consumption of alcohol
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001948
Descripción
For the SUALUNWK textbox the 2 decimal point section is optional. Study teams are allowed to capture whole numbers if required. This item will be calculated by Inform.
Tipo de datos
float
Unidades de medida
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Descripción
This item will be calculated by Inform.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0038586
- UMLS CUI [1,2]
- C0332307
Similar models
Liver events
- StudyEvent: ODM
C0023884 (UMLS CUI [1,2])
C0422202 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C1711359 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1275400 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
C0011923 (UMLS CUI [1,2])
C1148474 (UMLS CUI [2,1])
C0002346 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
C3671772 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0560579 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])