Eltrombopag in Chronic ITP
Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedSeptember 25, 2019
September 1, 2019
1 year
September 23, 2019
September 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Measuring the platelet count response to eltrombopag in pediatric chronic ITP
6 months
Interventions
Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients
Eligibility Criteria
You may qualify if:
- Pediatric patients with chronic ITP aged 1 to 17 years.
- Platelet count is less than 30×109 per liter.
- Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.
You may not qualify if:
- Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase \>1.5 ULN, total bilirubin \>1.5 ULN)
- Patients with history of thrombotic/thromboembolic events.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Corman SL, Mohammad RA. Eltrombopag: a novel oral thrombopoietin receptor agonist. Ann Pharmacother. 2010 Jun;44(6):1072-9. doi: 10.1345/aph.1P042. Epub 2010 May 11.
PMID: 20460556BACKGROUNDBussel JB, de Miguel PG, Despotovic JM, Grainger JD, Sevilla J, Blanchette VS, Krishnamurti L, Connor P, David M, Boayue KB, Matthews DC, Lambert MP, Marcello LM, Iyengar M, Chan GW, Chagin KD, Theodore D, Bailey CK, Bakshi KK. Eltrombopag for the treatment of children with persistent and chronic immune thrombocytopenia (PETIT): a randomised, multicentre, placebo-controlled study. Lancet Haematol. 2015 Aug;2(8):e315-25. doi: 10.1016/S2352-3026(15)00114-3. Epub 2015 Jul 28.
PMID: 26688484BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 25, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2020
Study Completion
January 1, 2021
Last Updated
September 25, 2019
Record last verified: 2019-09