Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital

Immune Thrombocytopenic Purpura Clinical Trial

Official title:

Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835050
• Other study ID #: Soh-Med-22-11-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: Afndia A Mahmoud, resident
• Phone: 01276484457
• Email: afandeyatmahmoud[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Autoimmune diseases are characterized by various factors that contribute to a breakdown in self-tolerance, that is, the ability of the immune system to effectively distinguish self from non-self and to refrain from attacking self. Autoimmune diseases include a broad spectrum of disorders, such as idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, and inflammatory bowel disease. Although significant progress has been achieved in the development of approaches to the treatment of autoimmune diseases, the etiologies, and pathogenesis of autoimmune diseases remain obscure (Tao et al., 2016) Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L (Neunert et al., 2019).

ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months) (Provan et al., 2019). ITP usually has a chronic course in adults (Moulis et al., 2017) whereas approximately 8090% of children undergo spontaneous remission within weeks to months of disease onset (Heitink et al., 2018).

The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs) (Adiua et al., 2017).

Among these abnormalities include the increased number of the T helper 1 (Th1) cells (Panitsas et al.,2004). the decreased number or defective suppressive function of regulatory T cells (Tregs) (Yu et al., 2008) , and the

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months and older

Eligibility

Inclusion Criteria:

• Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia according to bone marrow findings .

Exclusion Criteria:

• Other causes of thrombocytopenia as:

• Hypersplenism.

• Bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes.

• patients on chemotherapy and radiation therapy for cancer management

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Diagnostic Test:
• serum interleukin 10 level
b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Audia S, Mahevas M, Samson M, Godeau B, Bonnotte B. Pathogenesis of immune thrombocytopenia. Autoimmun Rev. 2017 Jun;16(6):620-632. doi: 10.1016/j.autrev.2017.04.012. Epub 2017 Apr 17. — View Citation

Heitink-Polle KMJ, Uiterwaal CSPM, Porcelijn L, Tamminga RYJ, Smiers FJ, van Woerden NL, Wesseling J, Vidarsson G, Laarhoven AG, de Haas M, Bruin MCA; TIKI Investigators. Intravenous immunoglobulin vs observation in childhood immune thrombocytopenia: a randomized controlled trial. Blood. 2018 Aug 30;132(9):883-891. doi: 10.1182/blood-2018-02-830844. Epub 2018 Jun 26. — View Citation

Tao JH, Cheng M, Tang JP, Liu Q, Pan F, Li XP. Foxp3, Regulatory T Cell, and Autoimmune Diseases. Inflammation. 2017 Feb;40(1):328-339. doi: 10.1007/s10753-016-0470-8. — View Citation

Zhan Y, Hua F, Ji L, Wang W, Zou S, Wang X, Li F, Cheng Y. Polymorphisms of the IL-23R gene are associated with primary immune thrombocytopenia but not with the clinical outcome of pulsed high-dose dexamethasone therapy. Ann Hematol. 2013 Aug;92(8):1057-62. doi: 10.1007/s00277-013-1731-3. Epub 2013 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of serum interleukin 10 level in patients with ITP	b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)	16 months