ID
39068
Beskrivning
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 Slit lamp examination and biomicroscopy, indirect ophthalmoscopy and reflexes motility pressure form. All has to be filled in for screening, Day 1, all part visits, in case of early withdrawal and at follow-up (Months 3 and 6). Additionnaly it can be filled in as unscheduled form.
Länk
https://clinicaltrials.gov/ct2/show/NCT00908037
Nyckelord
Versioner (2)
- 2019-10-21 2019-10-21 -
- 2019-11-26 2019-11-26 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 november 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Slit lamp examination and biomicroscopy, indirect ophthalmoscopy, reflexes motility pressure
Beskrivning
Slit lamp examination
Alias
- UMLS CUI-1
- C0419360
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Fill in for both sides.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beskrivning
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beskrivning
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0042789
- UMLS CUI [1,5]
- C0205307
- UMLS CUI [1,6]
- C1514873
- UMLS CUI [1,7]
- C0087111
- UMLS CUI [1,8]
- C2348235
Beskrivning
Eye function Abnormal, affecting vision, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0542341
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0392760
- UMLS CUI [1,5]
- C0042789
- UMLS CUI [1,6]
- C2348235
Beskrivning
Cortical opacity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C2938874
Beskrivning
Nuclear opacity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C2938873
Beskrivning
Posterior Subcapsular opacity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C0423344
Beskrivning
Slit lamp biomicroscopy of posterior pole features for each eye
Alias
- UMLS CUI-1
- C0419360
- UMLS CUI-2
- C0229092
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Fill in for both sides.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beskrivning
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beskrivning
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0042789
- UMLS CUI [1,5]
- C0205307
- UMLS CUI [1,6]
- C1514873
- UMLS CUI [1,7]
- C0087111
- UMLS CUI [1,8]
- C2348235
Beskrivning
Eye function Abnormal, affecting vision, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0542341
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0392760
- UMLS CUI [1,5]
- C0042789
- UMLS CUI [1,6]
- C2348235
Beskrivning
Indirect ophthalmoscopy
Alias
- UMLS CUI-1
- C1444582
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Fill in for both sides.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beskrivning
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beskrivning
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0042789
- UMLS CUI [1,5]
- C0205307
- UMLS CUI [1,6]
- C1514873
- UMLS CUI [1,7]
- C0087111
- UMLS CUI [1,8]
- C2348235
Beskrivning
Eye function Abnormal, affecting vision, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0542341
- UMLS CUI [1,3]
- C0205161
- UMLS CUI [1,4]
- C0392760
- UMLS CUI [1,5]
- C0042789
- UMLS CUI [1,6]
- C2348235
Beskrivning
Reflexes, Motility, Pressure
Alias
- UMLS CUI-1
- C0034929
- UMLS CUI-2
- C1510470
- UMLS CUI-3
- C0578862
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Fill in for both sides.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beskrivning
Pupil reflexes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034941
Beskrivning
Visual fields to confrontation
Datatyp
integer
Alias
- UMLS CUI [1]
- C1444674
Beskrivning
Eye Motility
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1510470
- UMLS CUI [1,2]
- C0015392
Beskrivning
Any other eye abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beskrivning
Intraocular pressure
Datatyp
integer
Alias
- UMLS CUI [1]
- C0578862
Similar models
Slit lamp examination and biomicroscopy, indirect ophthalmoscopy, reflexes motility pressure
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
C0423344 (UMLS CUI [1,2])
C0229092 (UMLS CUI-2)
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
C0243095 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0042789 (UMLS CUI [1,4])
C0205307 (UMLS CUI [1,5])
C1514873 (UMLS CUI [1,6])
C0087111 (UMLS CUI [1,7])
C2348235 (UMLS CUI [1,8])
C0542341 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,4])
C0042789 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
C1510470 (UMLS CUI-2)
C0578862 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])