ID
39066
Descripción
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 Ocular history form. It has to be filled in for screening and for Day 1.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palabras clave
Versiones (2)
- 17/10/19 17/10/19 -
- 26/11/19 26/11/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de noviembre de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Similar models
Ocular history
- StudyEvent: ODM
C0262926 (UMLS CUI-2)
C1299003 (UMLS CUI-3)
C0035648 (UMLS CUI-4)
C3665347 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C0035648 (UMLS CUI [1,2])
C0281991 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0035648 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0086543 (UMLS CUI [2,2])
C1833334 (UMLS CUI [2,3])
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0018670 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C0029180 (UMLS CUI [3,3])
C0035648 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C3282905 (UMLS CUI [2,3])
C0035648 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0015397 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C0035648 (UMLS CUI [1,2])
C0205404 (UMLS CUI [2,1])
C0015408 (UMLS CUI [2,2])
C0035648 (UMLS CUI [1,2])
C0205191 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0041625 (UMLS CUI [2,3])
C0035648 (UMLS CUI [1,2])
C0018099 (UMLS CUI [2])
C0035648 (UMLS CUI [1,2])
C0694535 (UMLS CUI [2])
C0035648 (UMLS CUI [1,2])
C0085762 (UMLS CUI [2])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])