ID
38507
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 ITP Therapy and the Medical/Surgical procedures form. It has to be filled in for repeating form.
Länk
https://clinicaltrials.gov/ct2/show/NCT00908037
Nyckelord
Versioner (3)
- 2019-10-23 2019-10-23 -
- 2019-10-23 2019-10-23 -
- 2019-12-05 2019-12-05 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
23 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
ITP Therapy, Medical/Surgical procedures
- StudyEvent: ODM
Beskrivning
Prior ITP Therapy
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0398650
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
(Trade Name preferred)
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0398650
- UMLS CUI [1,3]
- C2826302
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1516698
- UMLS CUI [1,4]
- C0805701
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C2348184
Beskrivning
Unit Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beskrivning
If you tick No, please specify the End Date in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beskrivning
ITP Therapy Treatment Type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0398650
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0332307
Beskrivning
Duration of Response
Datatyp
integer
Måttenheter
- Weeks
Alias
- UMLS CUI [1,1]
- C0237585
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beskrivning
Medical/Surgical procedures
Alias
- UMLS CUI-1
- C1948041
Beskrivning
In the original form this item is hidden.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C1948041
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C2826302
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C1140263
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C3898442
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beskrivning
Specific Procedure
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C2348235
Beskrivning
day month year
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2584899
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1948041
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1550373
- UMLS CUI [1,2]
- C0008902
Beskrivning
If you tick yes, please provide details on the AE or SAE forms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205161
- UMLS CUI [1,2]
- C0019080
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C1948041
- UMLS CUI [1,5]
- C0332281
- UMLS CUI [1,6]
- C0040034
Similar models
ITP Therapy, Medical/Surgical procedures
- StudyEvent: ODM
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C0398650 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,2])
C0398650 (UMLS CUI [1,3])
C1948041 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1948041 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948041 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,5])
C0040034 (UMLS CUI [1,6])