ID
39148
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 liver events form. It has to be filled in if a liver event occurs during study.
Lien
https://clinicaltrials.gov/ct2/show/NCT00908037
Mots-clés
Versions (2)
- 24/10/2019 24/10/2019 -
- 05/12/2019 05/12/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
5 décembre 2019
DOI
Pour une demande vous connecter.
Licence
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
Description
General Information
Alias
- UMLS CUI-1
- C1508263
Description
Item is not required. Please note the date and time of each you've ticked.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1302584
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0422202
Description
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
If you tick yes, please complete liver event forms and serious adverse event form immediately.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0023884
Description
alanine aminotransferase stop criterion
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Description
Age
Type de données
text
Alias
- UMLS CUI [1]
- C0001779
Description
If you tick yes, ensure Pregnancy Notification Form has been completed.
Type de données
text
Alias
- UMLS CUI [1]
- C0032961
Description
If you tick yes, please note the results of test in the following item.
Type de données
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
Description
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Description
If you tick yes, complete Liver Biopsy form.
Type de données
text
Alias
- UMLS CUI [1]
- C0193388
Description
If you tick yes, record on the appropriate Concomitant Medication form.
Type de données
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Description
Fast or significant dietary change
Type de données
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Description
Evaluation interval code
Type de données
text
Alias
- UMLS CUI [1]
- C2985767
Description
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
Onset of liver event
Type de données
text
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C0023884
Description
day month year. If the liver event occurred during/after treatment period record start date of lnvestigatlonal product for that treatment period.
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Description
investigational product Start date not applicable
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Description
day month year. If the liver event occurred during/after treatment period record end date of lnvestigatlonal product for that treatment period.
Type de données
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Description
investigational product end date not applicable
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Description
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031328
Description
Design notes: An unscheduled PK sample must be obtained within 72 hours of last dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0031328
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Description
Sample Identifier/Sample Number Pharmacokinetics
Type de données
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Description
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Description
Specific Condition
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Description
Tick only one response for each condition
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Description
Drug related liver disease condition (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Description
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
Item is not required
Type de données
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Specific condition
Type de données
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Item is not required
Type de données
text
Alias
- UMLS CUI [1]
- C2826302
Description
Item is not required
Type de données
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Description
Item is not required
Type de données
text
Alias
- UMLS CUI [1]
- C3898442
Description
Item is not required
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
This item is optional
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
- UMLS CUI [1,3]
- C0205394
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Disease
Type de données
integer
Alias
- UMLS CUI [1]
- C0012634
Description
Presence of disease
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Description
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
Description
Consumption of alcohol
Type de données
text
Alias
- UMLS CUI [1]
- C0001948
Description
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.
Type de données
float
Unités de mesure
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Description
This item will be calculated by Inform.
Type de données
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])