ID
39143
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 Concomitant medication form for documentation of any concomitant agents taken throughout the study. In case of concomitant medication affecting ocular health, the information about those medications should be given (additionally?) in a second version of this form concerning concomitant medication affecting ocular health.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palavras-chave
Versões (2)
- 23/10/2019 23/10/2019 -
- 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
Concomitant medication (all or affecting ocular health)
- StudyEvent: ODM
Descrição
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Descrição
Sequence Number
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C2347852
Descrição
(Trade Name preferred)
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0013227
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2826302
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Descrição
Unit Dose
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0869039
- UMLS CUI [1,2]
- C2347852
Descrição
Units
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Descrição
Frequency
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Descrição
Not necessary for form about "concomitant medication affecting ocular health".
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Descrição
Not necessary for form about "concomitant medication affecting ocular health".
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C2347852
Descrição
day month year
Tipo de dados
partialDate
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0808070
Descrição
Not necessary for form about "concomitant medication affecting ocular health".
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1883727
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2603343
Descrição
If you tick No, please specify the End Date in the following item.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Descrição
day month year
Tipo de dados
partialDate
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Descrição
Only for concomitant medication affecting ocular health version of this form. In the original this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332307
Similar models
Concomitant medication (all or affecting ocular health)
- StudyEvent: ODM
C0332307 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1883727 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2603343 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])