ID
38507
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 ITP Therapy and the Medical/Surgical procedures form. It has to be filled in for repeating form.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Stichworte
Versionen (3)
- 23.10.19 23.10.19 -
- 23.10.19 23.10.19 -
- 05.12.19 05.12.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
23. Oktober 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
ITP Therapy, Medical/Surgical procedures
- StudyEvent: ODM
Beschreibung
Prior ITP Therapy
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0398650
Beschreibung
In the original form this item is hidden.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0398650
- UMLS CUI [1,3]
- C2826302
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C1516698
- UMLS CUI [1,4]
- C0805701
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1276413
- UMLS CUI [1,2]
- C2348184
Beschreibung
Unit Dose
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
day month year
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschreibung
If you tick No, please specify the End Date in the following item.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschreibung
day month year
Datentyp
partialDate
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschreibung
ITP Therapy Treatment Type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0398650
- UMLS CUI [1,2]
- C0087111
- UMLS CUI [1,3]
- C0332307
Beschreibung
Duration of Response
Datentyp
integer
Maßeinheiten
- Weeks
Alias
- UMLS CUI [1,1]
- C0237585
- UMLS CUI [1,2]
- C1514463
- UMLS CUI [1,3]
- C0398650
Beschreibung
Medical/Surgical procedures
Alias
- UMLS CUI-1
- C1948041
Beschreibung
In the original form this item is hidden.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C1948041
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C2826302
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C1140263
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C3898442
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Specific Procedure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1948041
- UMLS CUI [1,2]
- C2348235
Beschreibung
day month year
Datentyp
partialDate
Alias
- UMLS CUI [1]
- C2584899
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1948041
Beschreibung
In the original form this item is hidden.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1550373
- UMLS CUI [1,2]
- C0008902
Beschreibung
If you tick yes, please provide details on the AE or SAE forms
Datentyp
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
Ähnliche Modelle
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])