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

October 22, 2019 updated by: Safaa AA Khaled, Assiut University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group on high dose dexamethasone, cyclosporin and rituximab
Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.
Diagnostic test: Serological assay for blood born viral hepatitis
Qualitative PCR for patients with hepatitis C antibody positive
Other Names:
  • Qualitative Polymerase chain reaction (PCR)
Diagnostic test: Quantitative microbiological test for HCV
Quantitative PCR in those with proven HCV infection
Active Comparator: Group on steroids only
Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.
Diagnostic test: Serological assay for blood born viral hepatitis
Qualitative PCR for patients with hepatitis C antibody positive
Other Names:
  • Qualitative Polymerase chain reaction (PCR)
Diagnostic test: Quantitative microbiological test for HCV
Quantitative PCR in those with proven HCV infection
Placebo Comparator: Placebo group
Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).
Diagnostic test: Serological assay for blood born viral hepatitis
Qualitative PCR for patients with hepatitis C antibody positive
Other Names:
  • Qualitative Polymerase chain reaction (PCR)
Diagnostic test: Quantitative microbiological test for HCV
Quantitative PCR in those with proven HCV infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence
Time Frame: 6-months
Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.
6-months
Platelet count
Time Frame: 6-months
Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count
6-months
Primary prevention
Time Frame: 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
One month
Risk factors
Time Frame: 6-months
Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed El yamany, Prof., Assiut University
  • Principal Investigator: Shymaa M Nageeb, MD, Assiut University
  • Principal Investigator: Eman NaserEldin, Prof, Assiut University
  • Study Director: Ahmed Khair, Ass. Prof., Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Skhaled21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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