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

Primary Purpose

Idiopathic Thrombocytopenic Purpura

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serological assay for blood born viral hepatitis
Quantitative microbiological test for HCV
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Idiopathic Thrombocytopenic Purpura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group on high dose dexamethasone, cyclosporin and rituximab

Group on steroids only

Placebo group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence
Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.
Platelet count
Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count
Primary prevention
Number of medical and paramedical staff who follow preventive measures for HCV and HBV in the hematology ward before and after an educational program
Risk factors
Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor

Secondary Outcome Measures

Full Information

First Posted
October 13, 2019
Last Updated
October 22, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04128358
Brief Title
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
Official Title
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group on high dose dexamethasone, cyclosporin and rituximab
Arm Type
Experimental
Arm Description
Egyptian patients with idiopathic thrombocytopenic purpura on high dose dexamethasone together with cyclosporine and rituximab.
Arm Title
Group on steroids only
Arm Type
Active Comparator
Arm Description
Egyptian patients with idiopathic thrombocytopenic purpura on parenteral or oral steroids.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Egyptian normal healthy volunteers who share on the President Initiative (100 Million Health).
Intervention Type
Diagnostic Test
Intervention Name(s)
Serological assay for blood born viral hepatitis
Other Intervention Name(s)
Qualitative Polymerase chain reaction (PCR)
Intervention Description
Qualitative PCR for patients with hepatitis C antibody positive
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative microbiological test for HCV
Intervention Description
Quantitative PCR in those with proven HCV infection
Primary Outcome Measure Information:
Title
Incidence
Description
Number of ITP patients on Triple therapy became infected with blood born viral hepatitis.
Time Frame
6-months
Title
Platelet count
Description
Number of ITP patients on Triple therapy infected with HCV or HBV and their platelet count
Time Frame
6-months
Title
Primary prevention
Description
Number of medical and paramedical staff who follow preventive measures for HCV and HBV in the hematology ward before and after an educational program
Time Frame
One month
Title
Risk factors
Description
Number of ITP patients who became infected with HCV or HBV after exposure to a risk factor
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Safaa A Khaled, Ass. Prof.
Phone
01064170058
Ext
002
Email
safaakhaled2003@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed El yamany, Prof.
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shymaa M Nageeb, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eman NaserEldin, Prof
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed Khair, Ass. Prof.
Organizational Affiliation
faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed El Menshawy, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
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Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?

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