- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102033
Eltrombopag in Chronic ITP
September 23, 2019 updated by: GM Abdelsalam, Assiut University
Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gehad M. Abdelsalam, M.B.B.Ch
- Phone Number: +201091294596
- Email: gehad011157@med.au.edu.eg
Study Contact Backup
- Name: Mohammed M. Hamdy Ghazaly, M.D.
- Phone Number: +201001296603
- Email: mohamed.ghazali1@med.au.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measuring the platelet count response to eltrombopag in pediatric chronic ITP
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2019
Primary Completion (Anticipated)
November 1, 2020
Study Completion (Anticipated)
January 1, 2021
Study Registration Dates
First Submitted
September 23, 2019
First Submitted That Met QC Criteria
September 23, 2019
First Posted (Actual)
September 25, 2019
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 23, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- Eltrombopag in ITP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immune Thrombocytopenia
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Institute of Hematology & Blood Diseases Hospital...Henan Cancer Hospital; Beijing Children's Hospital; Tianjin Medical University... and other collaboratorsRecruitingPrimary Immune Thrombocytopenia (ITP)China
-
argenxWithdrawnPrimary Immune Thrombocytopenia (ITP)
-
Novartis PharmaceuticalsRecruitingPrimary Immune Thrombocytopenia (ITP)China, United States, Spain, Singapore, Austria, Germany, Belgium, Italy, Japan, Czechia, Hong Kong, Hungary, Malaysia, Argentina, Bulgaria, Turkey, Vietnam, Australia, Thailand, Mexico, United Kingdom, France, Romania, Norway, India
-
University Children's Hospital BaselNovartis Pharmaceuticals; Stiftung zur Förderung medizinischer und biologischer... and other collaboratorsActive, not recruiting
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National Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationImmune Mediated Anemia | Immune Mediated Thrombocytopenia | Chronic GVHDUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingImmune Mediated Anemia | Immune Mediated Thrombocytopenia | Chronic GVHDUnited States
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Gruppo Italiano Malattie EMatologiche dell'AdultoCompletedAdult Patients | Immune Primary Thrombocytopenia | Splenectomy | TPO-mimeticsItaly
-
Changzhou No.2 People's HospitalRui Therapeutics Co., LtdNot yet recruitingThrombocytopenia Alloimmune
-
Nahda UniversityRecruiting
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingChronic Primary Immune Thrombocytopenia (ITP)China
Clinical Trials on Eltrombopag
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Novartis PharmaceuticalsCompletedPurpura, Thrombocytopenic, IdiopathicRussian Federation
-
Fondazione Progetto EmatologiaCompletedChronic Lymphocytic Leukemia | Purpura, Thrombocytopenic, Idiopathic | Non Hodgkin's Lymphoma | Autoimmune Thrombocytopenia | Autoimmune Thrombocytopenic PurpuraItaly
-
Weill Medical College of Cornell UniversityNovartisTerminatedImmune ThrombocytopeniaUnited States
-
Institute of Hematology & Blood Diseases Hospital...Xijing Hospital; Xi'an Central Hospital; The Second Hospital of Hebei Medical... and other collaboratorsActive, not recruitingPreviously Treated Primary Immune ThrombocytopeniaChina
-
Tel-Aviv Sourasky Medical CenterNovartisRecruitingB Cell Lymphoma | CART TreatmentIsrael
-
Gruppo Italiano Malattie EMatologiche dell'AdultoCompletedPrimacy Immune ThrombocytopeniaItaly
-
Novartis PharmaceuticalsCompletedPurpura, Thrombocytopaenic, Idiopathic
-
Nanfang Hospital of Southern Medical UniversityGuangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen... and other collaboratorsUnknownAcute Myeloid Leukemia | Thrombocytopenia | EltrombopagChina
-
IRCCS Policlinico S. MatteoCompleted
-
Dana-Farber Cancer InstituteTerminatedMultiple Myeloma | ThrombocytopeniaUnited States