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NCT04102033 Clinical Trial

Eltrombopag in Chronic ITP

Immune Thrombocytopenia Clinical Trial

Official title:
Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04102033
Other study ID # Eltrombopag in ITP
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date November 1, 2019
Est. completion date January 1, 2021

Study information
Verified date September 2019
Source Assiut University
Contact Gehad M. Abdelsalam, M.B.B.Ch
Phone +201091294596
Email gehad011157@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 1, 2021
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility Inclusion Criteria:

1. Pediatric patients with chronic ITP aged 1 to 17 years.

2. Platelet count is less than 30×109 per liter.

3. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.

Exclusion Criteria:

1. 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)

2. Patients with history of thrombotic/thromboembolic events.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eltrombopag
Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Bussel 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. Erratum in: Lancet Haematol. 2015 Oct;2(10):e407. — View Citation

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. Review. Erratum in: Ann Pharmacother. 2010 Jul-Aug;44(7-8):1352-3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measuring the platelet count response to eltrombopag in pediatric chronic ITP 6 months
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