Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam

• Conditions: Hepatitis C Infection
• Interventions: Other: Clinical examination

• Registration Number: NCT03601546
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-09-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with HCV infection	Clinical examination	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospital Viet Tiep; 🇻🇳 Hai Phong, Vietnam

CHU Nimes; 🇫🇷 Nîmes, France