ID
39138
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 Date of Visit/Assessment form. It has to be filled in for Screening, Day 1, all Visits of all parts and for all visits of follow-up.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palavras-chave
Versões (2)
- 04/11/2019 04/11/2019 -
- 05/12/2019 05/12/2019 - Sarah Riepenhausen
Titular dos direitos
GlaxoSmithKline
Transferido a
5 de dezembro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Date of Visit/Assessment
- StudyEvent: ODM
Descrição
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1]
- C1320303
- UMLS CUI [2]
- C2985720
Descrição
Only to be filled in for screening.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0449719
Descrição
If you tick yes, please note if subject is less than 6 years of age in the following item. Only to be filled in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0281588
Descrição
Only to be filled in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0001779
Descrição
If you tick yes, please check which exam (complete, lens) has been done in the following item. Not for the weekly follow-up visits (FUW1-FUW4).
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0200149
Descrição
Not for the weekly follow-up visits (FUW1-FUW4).
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0332307
Descrição
Only to be filled in for Screening, Day 1, P1W1-5, P1W7, P2W1-5, P2W7, P1W8-23, P3W8-23 and P3W8-30.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0022646
- UMLS CUI [1,2]
- C0431080
- UMLS CUI [1,3]
- C0884358
Descrição
Only to be filled in for Screening, Day 1, P1W1-7, P2W1-7, P1W8-23, P3W8-23 and P3W8-30.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0884358
- UMLS CUI [1,2]
- C2238079
Descrição
Only to be filled in for P1W1-5, P1W7, P2W1-5, P2W7, P1W8-23, P3W8-23 and P3W8-30.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1441506
- UMLS CUI [1,2]
- C0005778
- UMLS CUI [1,3]
- C0449381
Similar models
Date of Visit/Assessment
- StudyEvent: ODM
C2349954 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C0449719 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0431080 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C2238079 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
C0449381 (UMLS CUI [1,3])