Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy

October 31, 2019 updated by: Safaa AA Khaled

Aim of the work To estimate frequency of viral HB & C infection in ITP patients who received triple therapy in comparison with another group treated with steroids only.

To explore risk factors and routes of transmission of viral HB & C infection in ITP patients who received triple therapy and the another group treated with steroids .

- To assess preventive measures of viral HB& C infection in the hematology ward To investigate the influence of viral HB & C infection on clinical picture, response to treatment and side effects in ITP patients who received triple therapy or steroids.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary immune thrombocytopenia (ITP) is an autoimmune disorder characterized by isolated thrombocytopenia in the absence of other causes.ITP is mediated by antiplatelet autoantibodies. Antibody-coated platelets are phagocytosed by macrophages in the reticuloendothelial system, leading to accelerated platelet clearance. Macrophages also act as antigen-presenting cells interacting with CD8+ and CD4+ T cells that in turn stimulate antibody-producing B cells.This pathogenic loop sustains autoantibody production. T cell-mediated platelet lysis and megakaryocyte immunoinjury contribute to the diverse pathobiology of ITP.

Single-agent treatments have not been successful at inducing prolonged remission.With immunosuppressive monotherapy, ITP patients usually require prolonged treatment, leading to unpleasant and sometimes serious side effects.

Recent studies combining dexamethasone and rituximab in short courses have reported encouraging results.it is postulated that adding cyclosporine to this combination may induce a more enduring remission by also targeting T cells and thereby briefly suppressing all 3 immune cell types implicated in sustaining the pathogenic loop.

Suppressing these cells simultaneously has a risk of predisposing to serious infections.it is considered it appropriate to conduct a pilot study on a small number of patients with the aim of investigating the safety and efficacy of the triple therapy.

Infectious complications, mainly caused by the use of corticosteroids and other immunosuppressive agents, are a major cause of morbidity in patients with cITP. Moreover, infections may trigger autoimmune diseases and, at least theoretically, may be a complication of an already impaired immune system. It has been reported that children have an increased incidence of infection before diagnosis of ITP.

Hepatitis B (HBV) and C (HCV) virus infections are blood-borne viruses that pose major public health threats worldwide. The World Health Organization (WHO) report released in April 2017 on the status of hepatitis worldwide documented that 1.75 million new cases of HCV infection occurred in 2015, with about 71 million people already infected, the Eastern Mediterranean region has the highest HCV prevalence rate in the world According to WHO, in 2017 Egypt had the highest HCV prevalence rate in the world . According to the IHME in 2016, there were 4,002,706 men and 3,757,236 women with chronic HCV. HCV prevalence was estimated to be 11.9% among the general population (populations at relatively low risk of exposure to HCV, such as healthy children, blood donors, antenatal clinic attendees and pregnant women), 55.6% among populations at high risk (PWID, hemodialysis, multitransfused individuals and hemophiliacs), 14.3% among populations at intermediate risk (household contacts of HCV-infected individuals, prisoners, individuals with diabetes and healthcare workers), 56.0% among populations with liver-related conditions (acute viral hepatitis, liver cirrhosis, chronic liver disease, hepatocellular carcinoma and non-Hodgkin's lymphoma) and 35.0% among special clinical populations (dermatological manifestations, rheumatologic disorders and non-liver-related malignancies Thrombocytopenia can also complicate bleeding manifestations such as variceal bleeding. It may impede the initiation and continuation of antiviral therapy, potentially decreasing the probability of successful HCV reatment.Recent studies have evaluated the underlying mechanism of thrombocytopenia in chronic HCV infection and assessed the usefulness of several therapeutic options.

Besides hepatic complications, chronic HCV infection is also associated with several extra-hepatic manifestations including thrombocytopenia. Thrombocytopenia in chronic Hcv infection is a major problem, particularly in patients with advanced liver disease. The risk of serious bleeding with severe thrombocytopenia can prevent invasive procedures including biopsies for staging.

The pathophysiology of thrombocytopenia in patients with HCV infection is thought to be multifactorial. Besides inducing an autoimmune reaction with production of antiplatelet antibodies, the virus also causes direct bone marrow suppression with resulting thrombocytopenia , chronic HCV infection induced liver fibrosis and cirrhosis leads to portal hypertension with subsequent hypersplenism and sequestration of platelets, decreased the production of thrombopoeitin, and endothelial dysfunction, all of which can contribute to thrombocytopenia.Although uncommonly used in developed countries, interferon (IFN) and ribavirin used as part of anti-HCV therapy can also contribute to low platelet count.Hepatitis B virus (HBV) infection represents a significant global health problem, since almost one third of the worlds population has serological signs of previous or present infection, and that 240 million individuals are chronic hepatitis B surface antigen (HBsAg) carriers. Worldwide, low rates of serological HBsAg positivity (0.2%-0.5%) and signs of previous HBV contact [4%-6% HBsAg negative/anti-hepatitis B core antigen antibodies (anti-HBc)positive subjects] are registered in north western and central Europe, north America and Australia. On the contrary, the highest prevalences are reported in China, Southeast Asia and tropical Africa (chronicinfection 8%-20%, and previous exposure 70%-95%,respectively).

It is presently well known that medications such as glucocorticoids and anticancer treatments can interfere with the host immune system and blunt the control that it exerts over HBV replication, with the potential to cause viral reactivation (HBVr) in both HBsAg positive patients and individuals with serological signs of previous resolved HBV exposure. HBVr can assume various manifestations, spanning from asymptomatic hepatitis to life threatening fulminant liver failure. This risk is most common among patients undergoing treatment for hematological tumors or those receiving hematopoietic stem cell transplantation (HSCT). Nevertheless, also patients with solid tumors, immunological diseases and inflammatory bowel diseases are exposed to the risk of HBVr.The existence of an effective vaccination and a mature treatment schedule for HBV suggests that the potential for elimination of this virus as a major public health problem in Egypt exists. In a challenging economic climate, effective targeting of prevention and treatment strategies for both HBV and HCV is essential to make best use of limited resources in Egypt, however. Recent modelling work on HCV illustrates the potential power of intervention targeting in both reducing the risk of infection spread, and improving treatment outcomes, in the Egyptian context.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

On patients with Idiopathic thrombocytopenic Purpura treated with triple therapy or steroids only but more than 18 years and have no other blood diseases or not known to have hepatitis B and C

Description

Inclusion Criteria:

  • ITP patients received triple therapy or steroids only more than 18 years old

Exclusion Criteria:

All ITP patient less than 18 years old or treated with other regimens except triple therapy or steroids.

Patients with other bleeding disorders ITP patients with known viral hepatitis B & C infection before triple therapy

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Group of ITP patients received triple therapy
Drug: triple therapy
Effect of treatment on immunity to obtain infection with hepatitis B&C
Other Names:
  • High dose dexamethasone together with cyclosporin and rituximab
Group 2
Group of ITP patients received steroids
Drug: Steroids
Oral or parenteral steroid therapy for ITP
Other Names:
  • Parenteral decadrone or oral hostacortine
Group 3
Normal control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate frequency of viral HB & C infection in ITP patients who received triple therapy in comparison with another group treated with steroids and risk factors affecting infection
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
1-To assess preventive measures of viral HB& C infection in the hematology ward 2-to asses effect of viral hepatitis b,c on clinical picture , response to treatment and side effects in ITP patients received triple therapy
Time Frame: 1year
1year

Collaborators and Investigators

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

Sponsor

Safaa AA Khaled

Investigators

  • Study Director: Mohammad Elyamany, Prof., Yamany1@yahoo.com
  • Principal Investigator: Shymaa Mohamed Nageeb, MD, Shymaanageeb1993@gmail.com

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

Helpful Links

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)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Viral hepatitis in ITP

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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