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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113915
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Safaa AA Khaled, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment
ITP - Immune Thrombocytopenic Purpura Viral Hepatitis Drug: triple therapy Drug: Steroids

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


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 Name: 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 Name: Parenteral decadrone or oral hostacortine

Group 3
Normal control group



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113915


Contacts
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Contact: Safaa A Khaled, Ass. Prof. 01064170058 ext 002 safaakhaled2003@gmail.com
Contact: Shymaa Mohamed Nageeb, MD 01032165735 Shymaanageeb1993@gmail.com

Sponsors and Collaborators
Safaa AA Khaled
Investigators
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Study Director: Mohammad Elyamany, Prof. Yamany1@yahoo.com
Principal Investigator: Shymaa Mohamed Nageeb, MD Shymaanageeb1993@gmail.com

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Safaa AA Khaled, Assisstant professor, Assiut University
ClinicalTrials.gov Identifier: NCT04113915    
Other Study ID Numbers: Viral hepatitis in ITP
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Cyclosporine
Dexamethasone
Cyclosporins