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Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam

NCT03670251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2022-04-01

No results posted yet for this study

Summary

In Vietnam, the prevalence of hepatitis C virus (HCV) infection is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the USA. After HCV diagnosis, HCV viral load quantification is crucial in order to distinguish recovered from active (on-going) HCV infection and hence identify those who need antiviral treatment to cure HCV infection. HCV viral load quantification is also important to assess treatment efficacy.

Currently, anti-HCV antibodies detection is available around the country. However, access to confirmation of HCV viremia remains scarce particularly in decentralized areas. One of the reason is the limited number of laboratories able to perform this complex biological measurement; moreover, these laboratories are situated only in large urban centres.

Blood sampling using DBS could help overcome this difficulty of access to a laboratory, and widen access to HCV viral load monitoring.

The present MOVIDA Hep study aims at validating the use of DBS to measure HCV viral load as compared to plasma (gold standard). A secondary objective is to evaluate the measurement of HCV core antigen on DBS. For this, 315 patients need to be enrolled form outpatient clinics in Hanoi. The laboratory in charge of these measurements would be the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam).

Conditions

  • Hepatitis C
  • Dried Blood Spot

Interventions

PROCEDURE

Blood sampling

Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Hanoi University of Public Health

    collaborator OTHER

  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Fabien TAIEB, MD, PhD, MPH · Institut Pasteur

  • Tuan Anh NGUYEN, MD, PhD · National Institute of Hygiene and Epidemiology (NIHE)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2019-07-11
Completion
2019-07-11

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670251 on ClinicalTrials.gov