ID
39145
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 End of treatment/Early withdrawal and unscheduled visit assessments forms as well as information on discontinuation of the investigational product.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palabras clave
Versiones (2)
- 4/11/19 4/11/19 -
- 5/12/19 5/12/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de diciembre 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
End of treatment/Early withdrawal, Unscheduled visit assessments; discontinuation of investigational product
Descripción
Early withdrawal or unscheduled assessment check questions
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C1279919
- UMLS CUI-4
- C2349954
Descripción
Haematology lab samples
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0018941
Descripción
Chemistry lab samples
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0005834
Descripción
Blood smear
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2238079
Descripción
Calculation of coagulation parameters
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1441506
- UMLS CUI [1,2]
- C0005789
Descripción
Renal assessments
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0232804
- UMLS CUI [1,2]
- C0022885
Descripción
PK sample
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031328
Descripción
Vital signs
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0518766
Descripción
If you tick yes, please check which examination has been done in the following item.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0200149
Descripción
Ophthalmic exams type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0332307
- UMLS CUI [1,2]
- C0200149
Descripción
Assessment of WHO bleeding scale
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0043237
- UMLS CUI [1,2]
- C3251812
- UMLS CUI [1,3]
- C0681889
Descripción
If you tick yes, please note if the subject is less than 6 years of age in the following item.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034380
Descripción
Age
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001779
Descripción
Investigational product discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Descripción
If you tick yes, please complete the primary reason in the following item. Only to fill in for End of treatmen/early withdrawal.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C0444930
- UMLS CUI [1,5]
- C2347804
Descripción
If you tick "Adverse event": Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Additionally check if the adverse event is a matter of pregnancy or if there is no subreason in the appropriate item. Select "Investigator discretion" or "Decision by subject or proxy" if none of the other primary reasons are appropriate. If you do so, please specify in the appropriate items.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0205225
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0444930
- UMLS CUI [1,4]
- C0304229
Descripción
Adverse event, subreason
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0392360
Descripción
Investigator discretion, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Descripción
Decision by subject or proxy, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0422727
- UMLS CUI [1,3]
- C0679006
- UMLS CUI [2,1]
- C2348235
- UMLS CUI [2,2]
- C0422727
- UMLS CUI [2,3]
- C0600420
- UMLS CUI [2,4]
- C0679006
Similar models
End of treatment/Early withdrawal, Unscheduled visit assessments; discontinuation of investigational product
C3854240 (UMLS CUI-2)
C1279919 (UMLS CUI-3)
C2349954 (UMLS CUI-4)
C0018941 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
C0005789 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
C3251812 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
C0457454 (UMLS CUI-2)
C0457454 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0422727 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2,1])
C0422727 (UMLS CUI [2,2])
C0600420 (UMLS CUI [2,3])
C0679006 (UMLS CUI [2,4])