Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam (CoViet-C)

Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam

The purpose of this study is to evaluate the feasibility of implementing a cohort of patients with Hepatitis C in order to generate a larger cohort for future studies

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C Infection
• Intervention / Treatment: Other: Clinical examination

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Didier Laureillard, MD; Phone Number: 33.(0)04.66.68.41.49; Email: didier.laureillard@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Active, not recruiting
    • CHU Nimes
• Vietnam
  • Hai Phong, Vietnam
    • Recruiting
    • Hospital Viet Tiep
    • Contact: Vu Hai Vinh, MD; Phone Number: +84.(0)9.84.77.70.03; Email: vinhvuhai@gmail.com
    • Principal Investigator: Vu Hai Vinh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Hepititis C recruited during consultation in the infections and tropical disease service of the Viet Tiep hospital in Hai Phong, Vietnam

Description

Inclusion Criteria:

• The patient must have given their free and informed consent and signed the consent form
• The patient is at least 18 years old
• The patient is HCV RNA positive

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with HCV infection	Other: Clinical examination; Blood test and patient interview as for standard patient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient inclusion rate	Number of patients included/number of eligible patients	End of study: 12 months
Rate of missing data of patient variables	Current treatment, introduction of treatment, viral load, HCV genotype, fibrosis stage, HIV co-infection, drug consumption, alcohol consumption, methadone treatment,	Day 0-1
Lost to follow-up rate		Month 6
Lost to follow-up rate		Month 12
Archival of all signed consent forms		End of study: Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social-demographic characteristics of patients at inclusion	age, sex, weight, height, pregnancy test,	Day 0
drug and alcohol consumption,	type and amount	Day 0
treatment at inclusion		Day 0
commencement of treat		Day 1
initial HCV viral load,	UI/ml	Day 0
HCV genotype		Day 0
Fibrosis stage		Day 0
HIV viral load	Copies/ml	Day 0
Lymphocyte T4 level	Number of CD4 lymphocytes/mm3	Day 0
Fibrosis stage	Fibroscan result	Day 0
Hepatic ultrasound		Day 0
Transaminase levels	Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase	Day 0
HIV co-infection	Yes/no	Day 0
Hepititis B co-infection	Yes/no	Day 0
Methadone treatment	Yes/no	Day 0
Access to health cover	Yes/no	Day 0
Commencement of treatment	Yes/no	Day 1
Type of treatment		Day 0
Treatment side effects		ay
Early viral response	Undetectable HCV RNA	Week 4
Sustained viral response	Undetectable HCV RNA	Week 12
HCV re-infection	Yes/no	Month 12
Risk factors associated with reinfection		3 months after clearance

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Didier Laureillard, MD, CHU Nimes

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2018
• Primary Completion (ANTICIPATED): August 31, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: NIMAO/2016-08/DL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No