ID
39148
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 liver events form. It has to be filled in if a liver event occurs during study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00908037
Nyckelord
Versioner (2)
- 2019-10-24 2019-10-24 -
- 2019-12-05 2019-12-05 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 december 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Liver events
- StudyEvent: ODM
Beskrivning
General Information
Alias
- UMLS CUI-1
- C1508263
Beskrivning
Item is not required. Please note the date and time of each you've ticked.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0422202
- UMLS CUI [1,2]
- C0023884
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C1302584
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0422202
Beskrivning
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
If you tick yes, please complete liver event forms and serious adverse event form immediately.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0023884
Beskrivning
alanine aminotransferase stop criterion
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0151905
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2700357
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0541979
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2746065
- UMLS CUI [1,3]
- C0243161
Beskrivning
Age
Datatyp
text
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
If you tick yes, ensure Pregnancy Notification Form has been completed.
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
If you tick yes, please note the results of test in the following item.
Datatyp
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
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0011923
Beskrivning
If you tick yes, complete Liver Biopsy form.
Datatyp
text
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
If you tick yes, record on the appropriate Concomitant Medication form.
Datatyp
text
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2,1]
- C1148474
- UMLS CUI [2,2]
- C0002346
- UMLS CUI [3]
- C0242295
- UMLS CUI [4]
- C0086190
Beskrivning
Fast or significant dietary change
Datatyp
text
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Beskrivning
Evaluation interval code
Datatyp
text
Alias
- UMLS CUI [1]
- C2985767
Beskrivning
Investigational product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
Onset of liver event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2985916
- UMLS CUI [1,2]
- C0023884
Beskrivning
day month year. If the liver event occurred during/after treatment period record start date of lnvestigatlonal product for that treatment period.
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
Beskrivning
investigational product Start date not applicable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beskrivning
day month year. If the liver event occurred during/after treatment period record end date of lnvestigatlonal product for that treatment period.
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
Beskrivning
investigational product end date not applicable
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272460
Beskrivning
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031328
Beskrivning
Design notes: An unscheduled PK sample must be obtained within 72 hours of last dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0178913
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0031328
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Beskrivning
Sample Identifier/Sample Number Pharmacokinetics
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Beskrivning
Liver disease medical conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0262926
Beskrivning
Specific Condition
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Tick only one response for each condition
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beskrivning
Drug related liver disease condition (All drugs including lnvestigational Product)
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Beskrivning
Other liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Beskrivning
Item is not required
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
Specific condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1]
- C2826302
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1]
- C3898442
Beskrivning
Item is not required
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
This item is optional
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0023895
- UMLS CUI [1,3]
- C0205394
Beskrivning
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Beskrivning
Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Presence of disease
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3854307
- UMLS CUI [1,2]
- C0012634
Beskrivning
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
Beskrivning
Consumption of alcohol
Datatyp
text
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
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.
Datatyp
float
Måttenheter
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beskrivning
This item will be calculated by Inform.
Datatyp
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])