ID
38408
Descrizione
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 demography form. It has to be filled in for screening.
collegamento
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
versioni (1)
- 16/10/19 16/10/19 -
Titolare del copyright
GlaxoSmithKline
Caricato su
16 ottobre 2019
DOI
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Licenza
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Demography
- StudyEvent: ODM
Descrizione
Demography
Alias
- UMLS CUI-1
- C0011298
Descrizione
Ethnicity
Alias
- UMLS CUI-1
- C0015031
Descrizione
Geographic ancestry
Alias
- UMLS CUI-1
- C3841890
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1515945
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C4540996
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1556094
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0238697
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1513907
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Descrizione
Check all that apply
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0043157
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Demography
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])