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Eltrombopag in Chronic ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102033
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
GM Abdelsalam, Assiut University

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

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Eltrombopag Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : January 1, 2021



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


Primary Outcome Measures :
  1. Measuring the platelet count response to eltrombopag in pediatric chronic ITP [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102033


Contacts
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Contact: Gehad M. Abdelsalam, M.B.B.Ch +201091294596 gehad011157@med.au.edu.eg
Contact: Mohammed M. Hamdy Ghazaly, M.D. +201001296603 mohamed.ghazali1@med.au.edu.eg

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: GM Abdelsalam, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04102033    
Other Study ID Numbers: Eltrombopag in ITP
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms