Clinical trial NCT04128358: Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
Official title: Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Thrombocytopenic Purpura
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial aimed to assess the effect of strong immunosuppression in patients with ITP on Triple therapy on acquiring viral hepatitis infection C or B.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Normal healthy Egyptians on the age range from 18-85.
* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence
timeFrame: 6-months
measure: Platelet count
timeFrame: 6-months
measure: Primary prevention
timeFrame: One month
measure: Risk factors
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Mohamed El yamany, Prof.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Shymaa M Nageeb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Eman NaserEldin, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of medicine
name: Ahmed Khair, Ass. Prof.
role: STUDY_DIRECTOR
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