ID

38785

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 Phase conclusion form. It just has to be filled in after completion of Week 4 FU.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Palabras clave

Versiones (3)
  1. 21/10/19 21/10/19 -
  2. 4/11/19 4/11/19 -
  3. 26/11/19 26/11/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de noviembre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

Inglés

Phase conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Phase conclusion
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Phase conclusion
Descripción

Phase conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0205390
Did the subject withdraw from the analysis phase of the study?
Descripción

If the subject met the definition of a protocol completer = 'No' and enter the date the subject completed treatment/Week 4 follow up (depending on amendment status at site at that time) If the subject did not meet the definition of a protocol completer = 'Yes', the date the subject failed to complete (e.g., date study treatment was prematurely and permanently stopped) and enter the reason the subject did not complete

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0936012
UMLS CUI [1,3]
C0205390
Date of phase completion or withdrawal
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1549507
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C2349954
Primary reason for withdrawal
Descripción

If you tick adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Only tick Investigator discretion if none of the other primary reasons are appropriate. If you tick Investigator discretion, please specify in the following item.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
If primary reason for withdrawal is Investigator discretion, please specify
Descripción

Subject withdrawal, Investigator discretion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008961
UMLS CUI [1,4]
C0022423
UMLS CUI [1,5]
C2348235
Data entered and accurate
Descripción

Attention Study Investigator Please complete the Phase Conclusion form according to the definitions in the instructions above. However, please only **sign** this form after completion of Week 4 FU for all subjects (both pre and post protocol amendment Is all data entered and accurate for all previous visits (including 4 weeks of follow up) and associated log pages? This data may be used for an interim analysis and some or all of this data may be submitted to regulatory authorities. If Yes, then click the Sign button at the bottom of this form to provide Interim data sign-off.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0008961
Investigators signature
Descripción

Investigators signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Monitor, tick or untick this box to require the investigator to re-sign the case book.
Descripción

By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state.This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1283174
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Similar models

Phase conclusion

1 formularios
  1. StudyEvent: ODM
    1. Phase conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Phase conclusion
C1707478 (UMLS CUI-1)
C0205390 (UMLS CUI-2)
Item
Did the subject withdraw from the analysis phase of the study?
text
C2349954 (UMLS CUI [1,1])
C0936012 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
Withdraw from analysis phase
Code List
Did the subject withdraw from the analysis phase of the study?
CL Item
No (N)
CL Item
Yes (Y)
Date of phase completion or withdrawal
Item
Date of phase completion or withdrawal
date
C1549507 (UMLS CUI [1])
C0011008 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Item
Primary reason for withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Lack of efficacy (2)
CL Item
Protocol deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Subject withdrawal, Investigator discretion
Item
If primary reason for withdrawal is Investigator discretion, please specify
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Data entered and accurate
Item
Data entered and accurate
boolean
C0750484 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Check
Item
Monitor, tick or untick this box to require the investigator to re-sign the case book.
boolean
C1283174 (UMLS CUI [1])
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