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

  1. 10/17/19 10/17/19 -
  2. 11/4/19 11/4/19 -
  3. 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

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

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

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Study conclusion
Description

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Date of study completion or withdrawal
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
Was the subject withdrawn from the study?
Description

If you tick yes, complete the primary reason for withdrawal in the following item.

Data type

text

Alias
UMLS CUI [1]
C2349954
Primary reason for withdrawal
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
If primary reason for withdrawal is Investigator discretion, please specify
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
Case book ready for signature
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
Office use 1
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C1524063
Office Use 2
Description

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1,1]
C0442603
UMLS CUI [1,2]
C0237753
Pregnancy information (female)
Description

Pregnancy information (female)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086287
Did the subject become pregnant during the study?
Description

If you tick yes, complete the paper Pregnancy Notification form

Data type

text

Alias
UMLS CUI [1]
C3828490
Pregnancy information (male)
Description

Pregnancy information (male)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
UMLS CUI-3
C0086582
Did a female partner of the male subject become pregnant during the study?
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
Case book signature
Description

Case book signature

Alias
UMLS CUI-1
C2346576
Investigator first name
Description

investigator first name

Data type

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1443235
Investigator last name
Description

investigator last name

Data type

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1301584
Signature date
Description

Signature date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
CRB Electronic Signature AffidavitBy my dated signature below, I, [First Name][Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Description

electronic signature

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

Study conclusion, Pregnancy information

Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Date of study completion or withdrawal
Item
Date of study completion or withdrawal
date
C1549507 (UMLS CUI [1])
C2349954 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
Was the subject withdrawn from the study?
text
C2349954 (UMLS CUI [1])
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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])
Case book ready for signature
Item
Case book ready for signature
boolean
C0684224 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
Office use 1
text
C0442603 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Code List
Office use 1
CL Item
No (N)
CL Item
Yes (Y)
Item
Office Use 2
integer
C0442603 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Code List
Office Use 2
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy information (female)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086287 (UMLS CUI-3)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Pregnancy information (male)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C0086582 (UMLS CUI-3)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0086287 (UMLS CUI [1,1])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
Item Group
Case book signature
C2346576 (UMLS CUI-1)
investigator first name
Item
Investigator first name
text
C2826892 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
investigator last name
Item
Investigator last name
text
C2826892 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Signature date
Item
Signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
electronic signature
Item
CRB Electronic Signature AffidavitBy my dated signature below, I, [First Name][Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and clicking the button marked Submit below.
text
C2346576 (UMLS CUI [1])

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