Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
CoViet-C
1 other identifier
observational
300
2 countries
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedAugust 9, 2021
August 1, 2021
3 years
July 17, 2018
August 6, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (23)
Social-demographic characteristics of patients at inclusion
Day 0
drug and alcohol consumption,
Day 0
treatment at inclusion
Day 0
commencement of treat
Day 1
initial HCV viral load,
Day 0
- +18 more secondary outcomes
Study Arms (1)
Patients with HCV infection
Interventions
Blood test and patient interview as for standard patient care
Eligibility Criteria
Patients with Hepititis C recruited during consultation in the infections and tropical disease service of the Viet Tiep hospital in Hai Phong, Vietnam
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Nimes
Nîmes, 30029, France
Hospital Viet Tiep
Haiphong, Vietnam
Biospecimen
frozen plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Laureillard, MD
CHU Nimes
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
July 26, 2018
Study Start
September 13, 2018
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
August 9, 2021
Record last verified: 2021-08