ID
39147
Beschreibung
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Stichworte
Versionen (2)
- 24.10.19 24.10.19 -
- 05.12.19 05.12.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. Dezember 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura NCT00908037
Liver Lab tests and viral tests for liver events
- StudyEvent: ODM
Beschreibung
Lab name and address
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1442065
- UMLS CUI-3
- C0027365
Beschreibung
Test set type
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0332307
Beschreibung
Laboratory ID
Datentyp
text
Alias
- UMLS CUI [1]
- C2986056
Beschreibung
If you tick "Different from Screening Lab", please provide the Name and adress of laboratory in the following items.
Datentyp
text
Alias
- UMLS CUI [1]
- C0022877
Beschreibung
Laboratory name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Laboratory Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Lab tests exclusive to liver events (Liver Lab)
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0022885
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschreibung
Fill in this itemgroup for each procedure.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Fill in the respective item if character or numeric result.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1274040
Beschreibung
Numeric result
Datentyp
float
Alias
- UMLS CUI [1]
- C2347373
Beschreibung
Character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2350015
- UMLS CUI [1,2]
- C1274040
Beschreibung
Viral tests for liver events
Alias
- UMLS CUI-1
- C1273421
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Fill in this itemgroup for each viral test.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1273421
Beschreibung
Fill in the respective item if character or numeric result.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1273421
- UMLS CUI [1,2]
- C1274040
Beschreibung
Numeric result
Datentyp
float
Alias
- UMLS CUI [1]
- C2347373
Beschreibung
Character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2350015
- UMLS CUI [1,2]
- C1274040
Beschreibung
Assay Version
Datentyp
text
Alias
- UMLS CUI [1]
- C2985700
Ähnliche Modelle
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])