Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

NCT04719338 | Completed

• 1 other identifier: occult HCV in dialysis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

occult HCV, direct antiviral drugs, haemodialysis

Outcome Measures

Primary Outcomes (1)

• Occult HCV infection

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

  6 months

Study Arms (1)

participants

EXPERIMENTAL

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 .

Diagnostic Test: presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .

Interventions

presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) . DIAGNOSTIC_TEST

samples of peripheral blood from each patient into EDTA tube will be collected and tested for HCV RNA in peripheral blood mononuclear cells (PBMCs) .

Also known as: occult HCV infection

participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Alexandria University

Alexandria, Egypt

Location

Related Publications (3)

• 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.

  PMID: 30293914 BACKGROUND

• 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.

  PMID: 28611267 BACKGROUND

• Naguib H, Abouelnaga SF, Elsayed MM. Occult hepatitis C virus infection in hemodialysis patients who achieved a sustained virological response to directly acting antiviral drugs: is it a concern? Int Urol Nephrol. 2024 Jan;56(1):217-222. doi: 10.1007/s11255-023-03621-1. Epub 2023 May 20.

  PMID: 37209238 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Mohamed Mamdouh Elsayed, MD

  Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University

  PRINCIPAL INVESTIGATOR

• Shady F Abouelnaga, MD

  fellow of Clinical and Chemical Pathology Department, Alexandria University Hospitals

  STUDY CHAIR

• Hend N Abd Elmoteleub, MD

  Lecturer of Hepatolgy and Internal Medicine Department, Faculty of Medicine, Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

EG (1)