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

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

Sponsors

Lead sponsor: Assiut University

Source Assiut University
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.

Overall Status Not yet recruiting
Start Date November 2019
Completion Date June 2021
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence 6-months
Platelet count 6-months
Primary prevention One month
Risk factors 6-months
Enrollment 180
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Serological assay for blood born viral hepatitis

Description: Qualitative PCR for patients with hepatitis C antibody positive

Other name: Qualitative Polymerase chain reaction (PCR)

Intervention type: Diagnostic Test

Intervention name: Quantitative microbiological test for HCV

Description: Quantitative PCR in those with proven HCV 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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last name: Safaa A Khaled, Ass. Prof.

Phone: 01064170058

Phone ext: 002

Email: [email protected]

Location
facility contact Assiut University Mohamed El Menshawy, Prof.
Location Countries

Egypt

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Assiut University

Investigator full name: Safaa AA Khaled

Investigator title: Clinical Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Group on high dose dexamethasone, cyclosporin and rituximab

Arm group type: Experimental

Description: Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.

Arm group label: Group on steroids only

Arm group type: Active Comparator

Description: Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.

Arm group label: Placebo group

Arm group type: Placebo Comparator

Description: Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov