Clinical Trials Logo

Clinical Trial Summary

Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. 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). Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP.NK cells can also modulate cellular immunity in ITP patients.


Clinical Trial Description

Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L.ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. 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).Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. Auto-Abs production often occurs due to the loss of self-tolerance and increased stimulation of the immune system. The immune system includes a variety of B- and T cells which cooperate with each other in T-cell-dependent antibody production reactions and play significant roles in humoral and cellular immunity. Although the pathogenesis of ITP has not been clearly understood, the autoreactive B- and T cells have been directly and indirectly involved in Auto-Abs production, respectively. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP. It can be stated that CD4+ T cells are indirectly involved in ITP pathogenesis by inducing the increased activity of B cells during Auto-Abs production. Cytotoxic T lymphocytes (CTLs) are another subgroup of T lymphocytes characterized by the expression of CD8+ surface marker, destroying the pathogenic factors via granzyme and perforin production. These cells are increased in ITP patients and are involved in platelet destruction via augmented production of granzyme and perforin. NK cells can also modulate cellular immunity in ITP patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05093257
Study type Observational
Source Sohag University
Contact Sara M Hashem
Phone 01024758746
Email sara011095@med.sohag.edu.eg
Status Not yet recruiting
Phase
Start date November 2021
Completion date December 2022

See also
  Status Clinical Trial Phase
Recruiting NCT01255332 - Helicobacter Pylori Immune Thrombocytopenic Purpura Phase 2
Completed NCT02077192 - Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP) Phase 3
Completed NCT01719692 - Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia N/A
Completed NCT01621204 - A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients Phase 3
Completed NCT01730352 - Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients Phase 2/Phase 3
Completed NCT01713855 - Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura N/A
Completed NCT01672151 - Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia N/A
Completed NCT01390649 - A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP) Phase 4
Completed NCT01439321 - Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim N/A
Completed NCT00774202 - Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP Phase 2/Phase 3
Completed NCT02273960 - Study to Evaluate Safety and Efficacy in Adult Subjects With ITP Phase 1/Phase 2
Not yet recruiting NCT05585944 - " Effect of Single-nucleotide Polymorphism of CD40 Gene rs1883832 C/T on the Risk of Immune Thrombocytopenic Purpura " N/A
Recruiting NCT03177629 - H. Pylori Eradication for Moderate ITP Phase 3
Not yet recruiting NCT05835050 - Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital N/A
Active, not recruiting NCT03395210 - A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP) Phase 2
Completed NCT00621894 - Oral LGD-4665 Versus Placebo in Adults With Immune Thrombocytopenic Purpura (ITP) for 6 Weeks Plus Open Treatment Continuation Phase 2
Not yet recruiting NCT06444477 - Molecular Analysis of Thrombocytopenia and Cancer (MATAC): Investigating Antigenic Mimicry Between Platelets and Tumor Cells in Patients With Immune Thrombocytopenia (ITP) Associated With Cancer
Completed NCT01652599 - Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT Phase 2
Completed NCT00426270 - Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults Phase 3
Completed NCT02085993 - Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training N/A