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Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring occult HCV, direct antiviral drugs, haemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients on regular hemodialysis treatment for more than 6 months.
  • Achieved sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs).

Exclusion Criteria:

-

Sites / Locations

  • Faculty of Medicine, Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

participants

Arm Description

Immediately after confirmation of 24 weeks SVR after the end of treatment, we will collect samples of peripheral blood from each patient into EDTA tube and test for HCV RNA in peripheral blood mononuclear cells (PBMCs) . All patients included in this study will be subjected to full history taking and thorough clinical examination. The initial pre treatment data of the patients will be revised including body mass index (BMI), pre treatment status (naïve,experienced), pretreatment viral load by sensitive real-time HCV PCR technique, liver function tests, complete blood count, prothrombin time, international normalized ratio , Child-Pugh score, MELD score and FIB-4 score .

Outcomes

Primary Outcome Measures

Occult HCV infection
By assessing presence of HCV RNA in peripheral blood mononuclear cells (PBMCs)

Secondary Outcome Measures

Full Information

First Posted
January 17, 2021
Last Updated
April 13, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04719338
Brief Title
Occult HCV Infection After DAAD Treatment in Haemodialysis Patients
Official Title
Occult Hepatitis C Virus Infection In Hemodialysis Patients Who Achieved A Sustained Virological Response To Directly Acting Antiviral Drugs: Is It A Concern ?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This research aims to evaluate the prevalence and predictors of Occult HCV among hemodialysis (HD) patients who achieved 24 weeks sustained virological response (SVR) after treatment with direct-acting antiviral agents (DAA) by detection of viral RNA in their peripheral blood mononuclear cells.
Detailed Description
In maintenance hemodialysis (MHD) patients, hepatitis C virus (HCV) infection is common and may be associated with poor clinical outcomes. A lot of treatment options for HCV have rapidly evolved over the past 5 years and various treatment choices for patients with advanced CKD are currently available.1 The reappearance of HCV infection months or years after sustained virologic response (SVR) may be due to the persistence of HCV in tissue cells in spite of being undetected in serum. This situation is known as occult hepatitis C infection (OCI).2 OCI is now a challenging entity in the field of post hepatitis management and follow-up. OCI is described when HCV-RNA is detectable in liver and/or peripheral blood mononuclear cells (PBMCs) in patients with undetectable serum HCV-RNA. To our knowledge , this is the first research to issue this problem in dialysis patients after treatment with direct acting antiviral drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
occult HCV, direct antiviral drugs, haemodialysis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This research is a cross sectional study. Target population: thirty patients with end-stage renal disease (ESRD) receiving hemodialysis treatment from different dialysis centers in Alexandria will be enrolled in the study after achieving sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs).will be screened for the presence of occult HCV infection.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participants
Arm Type
Experimental
Arm Description
Immediately after confirmation of 24 weeks SVR after the end of treatment, we will collect samples of peripheral blood from each patient into EDTA tube and test for HCV RNA in peripheral blood mononuclear cells (PBMCs) . All patients included in this study will be subjected to full history taking and thorough clinical examination. The initial pre treatment data of the patients will be revised including body mass index (BMI), pre treatment status (naïve,experienced), pretreatment viral load by sensitive real-time HCV PCR technique, liver function tests, complete blood count, prothrombin time, international normalized ratio , Child-Pugh score, MELD score and FIB-4 score .
Intervention Type
Diagnostic Test
Intervention Name(s)
presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .
Other Intervention Name(s)
occult HCV infection
Intervention Description
samples of peripheral blood from each patient into EDTA tube will be collected and tested for HCV RNA in peripheral blood mononuclear cells (PBMCs) .
Primary Outcome Measure Information:
Title
Occult HCV infection
Description
By assessing presence of HCV RNA in peripheral blood mononuclear cells (PBMCs)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients on regular hemodialysis treatment for more than 6 months. Achieved sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs). Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Mamdouh Elsayed, MD
Organizational Affiliation
Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shady F Abouelnaga, MD
Organizational Affiliation
fellow of Clinical and Chemical Pathology Department, Alexandria University Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hend N Abd Elmoteleub, MD
Organizational Affiliation
Lecturer of Hepatolgy and Internal Medicine Department, Faculty of Medicine, Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30293914
Citation
Maduell F, Belmar L, Ugalde J, Laguno M, Martinez-Rebollar M, Ojeda R, Arias M, Rodas L, Rossi F, Llovet LP, Gonzalez LN, Mallolas J, Londono MC. Elimination of hepatitis C virus infection from a hemodialysis unit and impact of treatment on the control of anemia. Gastroenterol Hepatol. 2019 Mar;42(3):164-170. doi: 10.1016/j.gastrohep.2018.07.015. Epub 2018 Oct 4. English, Spanish.
Results Reference
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PubMed Identifier
28611267
Citation
Naghdi R, Ranjbar M, Bokharaei-Salim F, Keyvani H, Savaj S, Ossareh S, Shirali A, Mohammad-Alizadeh AH. Occult Hepatitis C Infection Among Hemodialysis Patients: A Prevalence Study. Ann Hepatol. 2017 Jul-Aug;16(4):510-513. doi: 10.5604/01.3001.0010.0277.
Results Reference
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Learn more about this trial

Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

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