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

NCT04128358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-10-24

No results posted yet for this study

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

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DIAGNOSTIC_TEST

Serological assay for blood born viral hepatitis

Qualitative PCR for patients with hepatitis C antibody positive

DIAGNOSTIC_TEST

Quantitative microbiological test for HCV

Quantitative PCR in those with proven HCV infection

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed El yamany, Prof. · Assiut University

  • Shymaa M Nageeb, MD · Assiut University

  • Eman NaserEldin, Prof · Assiut University

  • Ahmed Khair, Ass. Prof. · faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128358 on ClinicalTrials.gov