Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
Idiopathic thrombocytopenic purpura (ITP) is a benign hematological disorder characterized by
isolated thrombocytopenia. Development of antiplatelet autoantibodies is the main
pathogenetic mechanism in patients with ITP. However the exact pathogenesis of ITP is complex
in which megakaryocyte immune injury and T-cell mediated platelet destruction play
significant role. Accordingly treatment of ITP relies mainly on immunosuppression. Recently
triple regimen of high dose dexamethasone together with cyclosporine and rituximab was found
to induce prolonged remission in patients with ITP compared with single agent
immunosuppression. On the other hand this regimen suppresses all immune cells thus
predisposing patient to serious infections, which is the main cause of morbidity in ITP
furthermore infection enhances autoimmunity.
This study will focus on viral hepatitis C and B infection in Egyptian patients with
idiopathic thrombocytopenic purpura on Triple therapy and aims to:
- Assess and improve preventive measures of blood born hepatitis infection in the
hematology ward in Egypt.
- Investigate influence of immunosuppression on infection with blood born hepatitis on
Egyptian patients with ITP on Triple therapy.
- Study the impact of blood born hepatitis infection on clinical outcome on those
patients.
- Identify risk factors and routes of transmission of blood born viral hepatitis in the
hematology ward in Egypt
Blood born viral hepatitis is a type of viral hepatitis that is usually transmitted with
transfusion of blood and blood products. Accordingly patients with hematological disorders
are at higher risk for infection with blood born hepatitis as blood transfusion besides
regular sampling are integral parts in management of hematological patients. This was the
case in patients with ITP, however not all patients with ITP in need for regular platelet
transfusion. The mainstay of treatment of ITP is immunosuppression, that was mainly dependent
on parenteral or oral steroids for long time. Triple therapy was recently introduced for
treatment of patients with ITP it induces strong immunosuppression that could make patients
vulnerable to infections.
Several studies accused immunosuppression in patients with hematological malignancies under
chemotherapy to be a risk factor for infection with blood born hepatitis, as such triple
therapy could predispose patients with ITP to blood born viral hepatitis infection.
On the other hand infection with blood born hepatitis in patients with ITP on Triple therapy
could affect patient outcome and response to treatment. This is because thrombocytopenia is a
common extra hepatic manifestation of hepatitis C viral infection on its chronic form.
Egypt is a country with high prevalence of blood born viral hepatitis viral hepatitis C.
Recently, the president of Egypt elaborated an initiative (100 million Health) that was
managed with the Ministry of Health in all over the country. This initiative aimed to
eliminate blood born hepatitis particularly C from the Country.
This work will be conducted in Egypt and focused on ITP patients on Triple therapy to assess
their vulnerability for infection with blood born hepatitis as they are a particular sector
of the Egyptian population at higher risk for infection.
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