search
Back to results

Eltrombopag in Chronic ITP

Primary Purpose

Immune Thrombocytopenia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Eltrombopag
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Measuring the platelet count response to eltrombopag in pediatric chronic ITP

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2019
    Last Updated
    September 23, 2019
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04102033
    Brief Title
    Eltrombopag in Chronic ITP
    Official Title
    Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    January 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune Thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Eltrombopag
    Intervention Description
    Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients
    Primary Outcome Measure Information:
    Title
    Measuring the platelet count response to eltrombopag in pediatric chronic ITP
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gehad M. Abdelsalam, M.B.B.Ch
    Phone
    +201091294596
    Email
    gehad011157@med.au.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed M. Hamdy Ghazaly, M.D.
    Phone
    +201001296603
    Email
    mohamed.ghazali1@med.au.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20460556
    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. Erratum In: Ann Pharmacother. 2010 Jul-Aug;44(7-8):1352-3.
    Results Reference
    background
    PubMed Identifier
    26688484
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Eltrombopag in Chronic ITP

    We'll reach out to this number within 24 hrs