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Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128358
Enrollment
180
Registered
2019-10-16
Start date
2019-11-30
Completion date
2021-06-30
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura

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.

Interventions

DIAGNOSTIC_TESTSerological assay for blood born viral hepatitis

Qualitative PCR for patients with hepatitis C antibody positive

DIAGNOSTIC_TESTQuantitative microbiological test for HCV

Quantitative PCR in those with proven HCV infection

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence6-monthsNumber of ITP patients on Triple therapy became infected with blood born viral hepatitis.
Platelet count6-monthsNumber of ITP patients on Triple therapy infected with HCV or HBV and their platelet count
Primary preventionOne monthNumber of medical and paramedical staff who follow preventive measures for HCV and HBV in the hematology ward before and after an educational program
Risk factors6-monthsNumber of ITP patients who became infected with HCV or HBV after exposure to a risk factor

Countries

Egypt

Contacts

Primary ContactSafaa A Khaled, Ass. Prof.
safaakhaled2003@gmail.com01064170058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026