ID
39070
Description
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 study conclusion and pregnancy information form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Keywords
Versions (3)
- 10/17/19 10/17/19 -
- 11/4/19 11/4/19 -
- 11/26/19 11/26/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
November 26, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Study conclusion, Pregnancy information
- StudyEvent: ODM
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
day month year If the subject completed the study: Date of last contact must match the last scheduled study visit date. If the subject withdrew: Date of decision to withdraw must match the date of decision to withdraw the subject from the study before normal completion. Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.
Data type
date
Alias
- UMLS CUI [1]
- C1549507
- UMLS CUI [2,1]
- C2349954
- UMLS CUI [2,2]
- C0011008
Description
If you tick yes, complete the primary reason for withdrawal in the following item.
Data type
text
Alias
- UMLS CUI [1]
- C2349954
Description
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
Subject withdrawal, Investigator discretion
Data type
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
Description
In the original form this item is hidden. Data owner should check the box when data cleaning is complete
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205197
Description
In the original form this item is hidden.
Data type
text
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C1524063
Description
In the original form this item is hidden.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C0237753
Description
Pregnancy information (female)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C0086287
Description
Pregnancy information (male)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C0086582
Description
If you tick yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.
Data type
text
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3887537
- UMLS CUI [1,3]
- C3828490
Description
Case book signature
Alias
- UMLS CUI-1
- C2346576
Description
investigator first name
Data type
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1443235
Description
investigator last name
Data type
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1301584
Description
Signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
electronic signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Study conclusion, Pregnancy information
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C2349954 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0205197 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C0086287 (UMLS CUI-3)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])