ID
39068
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Trefwoorden
Versies (2)
- 21-10-19 21-10-19 -
- 26-11-19 26-11-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 november 2019
DOI
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Licentie
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
Beschrijving
Slit lamp examination
Alias
- UMLS CUI-1
- C0419360
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Fill in for both sides.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beschrijving
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beschrijving
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatype
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
Beschrijving
Eye function Abnormal, affecting vision, specification
Datatype
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
Beschrijving
Cortical opacity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C2938874
Beschrijving
Nuclear opacity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C2938873
Beschrijving
Posterior Subcapsular opacity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C0423344
Beschrijving
Slit lamp biomicroscopy of posterior pole features for each eye
Alias
- UMLS CUI-1
- C0419360
- UMLS CUI-2
- C0229092
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Fill in for both sides.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beschrijving
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beschrijving
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatype
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
Beschrijving
Eye function Abnormal, affecting vision, specification
Datatype
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
Beschrijving
Indirect ophthalmoscopy
Alias
- UMLS CUI-1
- C1444582
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Fill in for both sides.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beschrijving
If you tick " Abnormal, not affecting vision, requiring treatment" or "Abnormal, affecting vision", please specify for both in the following items.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0243095
Beschrijving
Eye finding Abnormal, not affecting vision but requiring treatment, specification
Datatype
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
Beschrijving
Eye function Abnormal, affecting vision, specification
Datatype
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
Beschrijving
Reflexes, Motility, Pressure
Alias
- UMLS CUI-1
- C0034929
- UMLS CUI-2
- C1510470
- UMLS CUI-3
- C0578862
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Fill in for both sides.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C0441987
Beschrijving
Pupil reflexes
Datatype
integer
Alias
- UMLS CUI [1]
- C0034941
Beschrijving
Visual fields to confrontation
Datatype
integer
Alias
- UMLS CUI [1]
- C1444674
Beschrijving
Eye Motility
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1510470
- UMLS CUI [1,2]
- C0015392
Beschrijving
Any other eye abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015392
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
Beschrijving
Intraocular pressure
Datatype
integer
Alias
- UMLS CUI [1]
- C0578862
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