ID
39139
Beschreibung
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
Stichworte
Versionen (2)
- 22.10.19 22.10.19 -
- 05.12.19 05.12.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. Dezember 2019
DOI
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Lizenz
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
Beschreibung
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0877248
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826302
- UMLS CUI [1,2]
- C0877248
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0877248
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0877248
Beschreibung
In the original form this item is hidden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0877248
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
If you tick "Recovered/Resolved" or "Recovered/Resolved with sequelae" provide End Date and Time
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
End Date and Time of AE
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
Frequency of AE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C1518404
Beschreibung
This item may be hidden if either the "Maximum Grade" or "Maximum Grade or Intensity" item has been used.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Beschreibung
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade or Intensity" item has been used Grade 5 is optional.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
Beschreibung
This item may be hidden if either the "Maximum Intensity" or "Maximum Grade" item has been used Grade 5 is optional.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [2,1]
- C0518690
- UMLS CUI [2,2]
- C0877248
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
text
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Patient withdrawn due to this AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschreibung
Relationship to Investigational Drug
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
If AE start and end time are used this item must be hidden. Hr(s), min(s)
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C1518404
Beschreibung
In the original form this item is hidden. Hr(s), min(s)
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Ähnliche Modelle
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])