CoViet-C: Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with HCV infection
|
Other: Clinical examination
Blood test and patient interview as for standard patient care
|
Outcome Measures
Primary Outcome Measures
- 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,
- 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
- Social-demographic characteristics of patients at inclusion [Day 0]
age, sex, weight, height, pregnancy test,
- drug and alcohol consumption, [Day 0]
type and amount
- treatment at inclusion [Day 0]
- commencement of treat [Day 1]
- initial HCV viral load, [Day 0]
UI/ml
- HCV genotype [Day 0]
- Fibrosis stage [Day 0]
- HIV viral load [Day 0]
Copies/ml
- Lymphocyte T4 level [Day 0]
Number of CD4 lymphocytes/mm3
- Fibrosis stage [Day 0]
Fibroscan result
- Hepatic ultrasound [Day 0]
- Transaminase levels [Day 0]
Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase
- HIV co-infection [Day 0]
Yes/no
- Hepititis B co-infection [Day 0]
Yes/no
- Methadone treatment [Day 0]
Yes/no
- Access to health cover [Day 0]
Yes/no
- Commencement of treatment [Day 1]
Yes/no
- Type of treatment [Day 0]
- Treatment side effects [ay]
- Early viral response [Week 4]
Undetectable HCV RNA
- Sustained viral response [Week 12]
Undetectable HCV RNA
- HCV re-infection [Month 12]
Yes/no
- Risk factors associated with reinfection [3 months after clearance]
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nimes | Nîmes | France | 30029 | |
| 2 | Hospital Viet Tiep | Hai Phong | Vietnam |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Didier Laureillard, MD, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2016-08/DL-01