Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal healthy Egyptians on the age range from 18-
- •Egyptian patients with ITP in age range from 18- 65 on high dose dexamethasone together with cyclosporin and rituximab .
- •Egyptian patients with ITP in age range from 18- 65 on parenteral or oral steriods.
排除标准
- •Age less than 18 years old.
- •Pregnancy
- •Thrombocytopenia other than ITP.
- •Patients with ITP but on other modalities of treatment.
- •Patients with blood born viral hepatitis infection before treatment with high dose dexamethasone together with cyclosporin and rituximab
研究组 & 干预措施
Group on high dose dexamethasone, cyclosporin and rituximab
Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.
干预措施: Serological assay for blood born viral hepatitis (Diagnostic Test)
Group on high dose dexamethasone, cyclosporin and rituximab
Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.
干预措施: Quantitative microbiological test for HCV (Diagnostic Test)
Group on steroids only
Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.
干预措施: Serological assay for blood born viral hepatitis (Diagnostic Test)
Group on steroids only
Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.
干预措施: Quantitative microbiological test for HCV (Diagnostic Test)
Placebo group
Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).
干预措施: Serological assay for blood born viral hepatitis (Diagnostic Test)
Placebo group
Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).
干预措施: Quantitative microbiological test for HCV (Diagnostic Test)
结局指标
主要结局
Incidence
时间窗: 6-months
Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.
Platelet count
时间窗: 6-months
Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count
Primary prevention
时间窗: One month
Number of medical and paramedical staff who follow preventive measures for HCV and HBV in the hematology ward before and after an educational program
Risk factors
时间窗: 6-months
Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor
次要结局
未报告次要终点
研究者
Safaa AA Khaled
Clinical Professor
Assiut University