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

Hepatitis C Infection Clinical Trial

— CoViet-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03601546
• Other study ID #: NIMAO/2016-08/DL-01
• Status: Recruiting
• Start date: September 13, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Didier Laureillard, MD
• Phone: 33.(0)04.66.68.41.49
• Email: didier.laureillard[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection

Intervention

Other:
• Clinical examination
Blood test and patient interview as for standard patient care

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes
Vietnam	Hospital Viet Tiep	Hai Phong

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Countries where clinical trial is conducted

France,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient inclusion rate	Number of patients included/number of eligible patients	End of study: 12 months
Primary	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
Primary	Lost to follow-up rate		Month 6
Primary	Lost to follow-up rate		Month 12
Primary	Archival of all signed consent forms		End of study: Month 12
Secondary	Social-demographic characteristics of patients at inclusion	age, sex, weight, height, pregnancy test,	Day 0
Secondary	drug and alcohol consumption,	type and amount	Day 0
Secondary	treatment at inclusion		Day 0
Secondary	commencement of treat		Day 1
Secondary	initial HCV viral load,	UI/ml	Day 0
Secondary	HCV genotype		Day 0
Secondary	Fibrosis stage		Day 0
Secondary	HIV viral load	Copies/ml	Day 0
Secondary	Lymphocyte T4 level	Number of CD4 lymphocytes/mm3	Day 0
Secondary	Fibrosis stage	Fibroscan result	Day 0
Secondary	Hepatic ultrasound		Day 0
Secondary	Transaminase levels	Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase	Day 0
Secondary	HIV co-infection	Yes/no	Day 0
Secondary	Hepititis B co-infection	Yes/no	Day 0
Secondary	Methadone treatment	Yes/no	Day 0
Secondary	Access to health cover	Yes/no	Day 0
Secondary	Commencement of treatment	Yes/no	Day 1
Secondary	Type of treatment		Day 0
Secondary	Treatment side effects		ay
Secondary	Early viral response	Undetectable HCV RNA	Week 4
Secondary	Sustained viral response	Undetectable HCV RNA	Week 12
Secondary	HCV re-infection	Yes/no	Month 12
Secondary	Risk factors associated with reinfection		3 months after clearance