Hepatitis C Infection
Conditions
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
Interventions
OTHERClinical examination
Blood test and patient interview as for standard patient care
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Archival of all signed consent forms | End of study: Month 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Countries
France, Vietnam
Contacts
PRINCIPAL_INVESTIGATORDidier Laureillard, MD
CHU Nimes
Outcome results
None listed