ID
38441
Beschrijving
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 Laboratories form. It contains the clinical chemistry, renal assessment, clinical haematology, clinical coagulaion and the blood smear result. It has to be filled in for screening and Day 1, for all visits of part 2 and part 3. Clinical chemistry and haematology also has to be filled in for thw weekly follow-up visits.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Trefwoorden
Versies (2)
- 17-10-19 17-10-19 -
- 26-11-19 26-11-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
17 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Similar models
Laboratories
- StudyEvent: ODM
C1442065 (UMLS CUI-2)
C0027365 (UMLS CUI-3)
C0022877 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1516048 (UMLS CUI-2)
C0430370 (UMLS CUI-3)
C0456984 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
C1516048 (UMLS CUI-2)
C0430397 (UMLS CUI-3)
C0456984 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0022646 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,2])
C0373595 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0373595 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C1096054 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1096054 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0456984 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0201721 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C0201721 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0474523 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0005790 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0005778 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0334044 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C0007634 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])