ID
39139
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 Non-serious adverse event form. It has to be filled in if a non-serious AE occurs during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palavras-chave
Versões (2)
- 22/10/2019 22/10/2019 -
- 05/12/2019 05/12/2019 - Sarah Riepenhausen
Titular dos direitos
GlaxoSmithKline
Transferido a
5 de dezembro 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
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
Descrição
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0877248
Descrição
Diagnosis Only (if known) Otherwise Sign/Symptom
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1518404
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0877248
Descrição
In the original form this item is hidden.
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0877248
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2697888
Descrição
If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae" provide End Date and Time
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1705586
Descrição
End Date and Time of AE
Tipo de dados
datetime
Alias
- UMLS CUI [1]
- C2826793
Descrição
Frequency of AE
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1518404
Descrição
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Descrição
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
Descrição
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0877248
Descrição
Action Taken with Investigational Product(s) as a Result of the AE
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2826626
Descrição
Patient withdrawn due to this AE
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Descrição
Relationship to Investigational Drug
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descrição
If AE start and end time are used this item must be hidden. Hr(s), min(s)
Tipo de dados
float
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Descrição
In the original form this item is hidden. Hr(s), min(s)
Tipo de dados
float
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Similar models
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])