ID
39147
Description
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 Liver Labs (Lab tests exclusive to liver events) and the viral tests for liver events form. It has to be filled in as repeating form.
Lien
https://clinicaltrials.gov/ct2/show/NCT00908037
Mots-clés
Versions (2)
- 24/10/2019 24/10/2019 -
- 05/12/2019 05/12/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
5 décembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura NCT00908037
Liver Lab tests and viral tests for liver events
- StudyEvent: ODM
Description
Lab name and address
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1442065
- UMLS CUI-3
- C0027365
Description
Test set type
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0332307
Description
Laboratory ID
Type de données
text
Alias
- UMLS CUI [1]
- C2986056
Description
If you tick "Different from Screening Lab", please provide the Name and adress of laboratory in the following items.
Type de données
text
Alias
- UMLS CUI [1]
- C0022877
Description
Laboratory name
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Laboratory Address
Type de données
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
Lab tests exclusive to liver events (Liver Lab)
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0022885
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
Fill in this itemgroup for each procedure.
Type de données
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Fill in the respective item if character or numeric result.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1274040
Description
Numeric result
Type de données
float
Alias
- UMLS CUI [1]
- C2347373
Description
Character result
Type de données
text
Alias
- UMLS CUI [1,1]
- C2350015
- UMLS CUI [1,2]
- C1274040
Description
Viral tests for liver events
Alias
- UMLS CUI-1
- C1273421
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Fill in this itemgroup for each viral test.
Type de données
integer
Alias
- UMLS CUI [1]
- C1273421
Description
Fill in the respective item if character or numeric result.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1273421
- UMLS CUI [1,2]
- C1274040
Description
Numeric result
Type de données
float
Alias
- UMLS CUI [1]
- C2347373
Description
Character result
Type de données
text
Alias
- UMLS CUI [1,1]
- C2350015
- UMLS CUI [1,2]
- C1274040
Description
Assay Version
Type de données
text
Alias
- UMLS CUI [1]
- C2985700
Similar models
Liver Lab tests and viral tests for liver events
- StudyEvent: ODM
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0022877 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])