ID
38782
Descrizione
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 Pharmacokinetics and Investigational products for PK form. It has to be filled in for Part 1 for all weeks (1-24/EW), for Part 2 for all weeks (1-7) and for all weeks of Part 3.
collegamento
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
versioni (1)
- 04/11/19 04/11/19 -
Titolare del copyright
GlaxoSmithKline
Caricato su
4 novembre 2019
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Pharmacokinetics, Investigational products for PK
- StudyEvent: ODM
Descrizione
Investigational product for PK Sampling
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0005834
Descrizione
Please check for which Dose relative to PK sample you'll fill in this itemgroup. Only to fill in for P1W6, P2W6 and for unscheduled.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Descrizione
In the original form this item is hidden.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0304229
Descrizione
Type of Investigational Product
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332307
Descrizione
If subject did not receive tablet but suspension, fill in the item "Suspension dose received".
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0039225
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1514756
Descrizione
If subject did not receive suspension but tablets, fill in the item "Tablets dose received".
Tipo di dati
integer
Unità di misura
- mg
Alias
- UMLS CUI [1,1]
- C0038960
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C1514756
Descrizione
In the original form this item is hidden.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0304229
Descrizione
Day month year
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Descrizione
00:00-23:59
Tipo di dati
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Descrizione
In the original form this item is hidden.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Descrizione
In the original form this item is hidden.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1705957
- UMLS CUI [1,2]
- C0304229
Descrizione
Vomit
Tipo di dati
text
Alias
- UMLS CUI [1]
- C0042963
Descrizione
In the original form this item is hidden.
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0010947
- UMLS CUI [1,2]
- C1706276
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Descrizione
Violation of interval between investigational product and diary product consumption
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1272706
- UMLS CUI [1,3]
- C0010947
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C1533734
Descrizione
Pharmacokinetics blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Descrizione
Day month year
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Descrizione
00:00-23:59
Tipo di dati
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Descrizione
Only to fill in for P1W6, P2W6 and for unscheduled.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0178602
Descrizione
day month year
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Descrizione
00:00-23:59
Tipo di dati
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0040223
Similar models
Pharmacokinetics, Investigational products for PK
- StudyEvent: ODM
C0031328 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514756 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1706276 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,2])
C0010947 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0005767 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])