ID
39141
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 investigational product form. It has to be filled in for Logs and repeats.
Länk
https://clinicaltrials.gov/ct2/show/NCT00908037
Nyckelord
Versioner (2)
- 2019-10-21 2019-10-21 -
- 2019-12-05 2019-12-05 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 december 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
Logs and repeats: Investigational product
- StudyEvent: ODM
Beskrivning
Investigational product
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0947323
Beskrivning
Total number of sachets/tablets dispensed
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beskrivning
Container number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beskrivning
If you tick yes, please note the date of return and the total number of sachets/tablets returned in the appropriate items. If you tick no, please specify in the appropriate item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332156
- UMLS CUI [1,2]
- C0304229
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0332156
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0011008
Beskrivning
Total number of sachets/tablets returned
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C2699071
- UMLS CUI [2,2]
- C0039225
Beskrivning
No return of investigational product, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0332156
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2348235
Beskrivning
In the original form this item is hidden
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3640652
Beskrivning
If subject did not receive tablet but suspension, fill in the item "Suspension dose received". If you tick alternating dose, please specify in the appropriate item.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0039225
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1514756
Beskrivning
Alternating dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332270
- UMLS CUI [1,2]
- C0039225
Beskrivning
If subject did not receive suspension but tablets, fill in the item "Tablets dose received".
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0038960
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C1514756
Beskrivning
Frequency
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439603
- UMLS CUI [1,2]
- C0304229
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0304229
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Beskrivning
In the original form this item is hidden.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705957
- UMLS CUI [1,2]
- C0304229
Beskrivning
Note: For Day 1 dosing, please enter Yes If you tick no, please record reason(s) in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C2349182
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0178602
- UMLS CUI [1,5]
- C1272706
- UMLS CUI [2,1]
- C2349182
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [2,3]
- C0347984
- UMLS CUI [2,4]
- C0178602
- UMLS CUI [2,5]
- C1272706
Beskrivning
No correct treatment/dose, reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C1298908
- UMLS CUI [1,3]
- C2349182
- UMLS CUI [1,4]
- C0087111
- UMLS CUI [2,1]
- C0392360
- UMLS CUI [2,2]
- C1298908
- UMLS CUI [2,3]
- C2349182
- UMLS CUI [2,4]
- C0178602
Similar models
Logs and repeats: Investigational product
- StudyEvent: ODM
C0947323 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
C0332156 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C3640652 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0039225 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514756 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
C2349182 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C1272706 (UMLS CUI [2,5])
C1298908 (UMLS CUI [1,2])
C2349182 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0392360 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C2349182 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])