Clinical Trials Logo
  1. Home
  2. Immune Thrombocytopenia
  3. NCT04102033
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)