ID
38782
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 Pharmacokinetics and Investigational products for PK form. It has to be filled in for Part 1 for all weeks (1-24/EW), for Part 2 for all weeks (1-7) and for all weeks of Part 3.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palavras-chave
Versões (1)
- 04/11/2019 04/11/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de novembro 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
Pharmacokinetics, Investigational products for PK
- StudyEvent: ODM
Descrição
Investigational product for PK Sampling
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0005834
Descrição
Please check for which Dose relative to PK sample you'll fill in this itemgroup. Only to fill in for P1W6, P2W6 and for unscheduled.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Descrição
In the original form this item is hidden.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C0304229
Descrição
Type of Investigational Product
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0332307
Descrição
If subject did not receive tablet but suspension, fill in the item "Suspension dose received".
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0039225
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1514756
Descrição
If subject did not receive suspension but tablets, fill in the item "Tablets dose received".
Tipo de dados
integer
Unidades de medida
- mg
Alias
- UMLS CUI [1,1]
- C0038960
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0178602
- UMLS CUI [1,4]
- C1514756
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C0304229
Descrição
Day month year
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0304229
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0304229
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1705957
- UMLS CUI [1,2]
- C0304229
Descrição
Vomit
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0042963
Descrição
In the original form this item is hidden.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0010947
- UMLS CUI [1,2]
- C1706276
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C1533734
Descrição
Violation of interval between investigational product and diary product consumption
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1272706
- UMLS CUI [1,3]
- C0010947
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C1533734
Descrição
Pharmacokinetics blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Descrição
Day month year
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0011008
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Descrição
Only to fill in for P1W6, P2W6 and for unscheduled.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0178602
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0011008
Descrição
00:00-23:59
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0040223
Similar models
Pharmacokinetics, Investigational products for PK
- StudyEvent: ODM
C0031328 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1514756 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1706276 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,2])
C0010947 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1533734 (UMLS CUI [1,5])
C0005767 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])