Hepatitis C InfectionCoViet-CNCT03601546
Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
An observational study of Hepatitis C Infection, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- Clinical examination
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Sep 2018to 3 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with Hepititis C recruited during consultation in the infections and tropical disease service of the Viet Tiep hospital in Hai Phong, Vietnam
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam
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
- Conditions
- Hepatitis C Infection
- Being tested
- Clinical examination
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
Blood test and patient interview as for standard patient care
| Study group | Role | What they receive |
|---|---|---|
| Patients with HCV infection | Not described Receives: Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient inclusion rate
Number of patients included/number of eligible patients
Measured: 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,
Measured: Day 0-1
Lost to follow-up rate
Measured: Month 6
Lost to follow-up rate
Measured: Month 12
Archival of all signed consent forms
Measured: End of study: Month 12
Secondary outcomes (23)
Social-demographic characteristics of patients at inclusion
age, sex, weight, height, pregnancy test,
Measured: Day 0
drug and alcohol consumption,
type and amount
Measured: Day 0
treatment at inclusion
Measured: Day 0
commencement of treat
Measured: Day 1
initial HCV viral load,
UI/ml
Measured: Day 0
HCV genotype
Measured: Day 0
Fibrosis stage
Measured: Day 0
HIV viral load
Copies/ml
Measured: Day 0
Lymphocyte T4 level
Number of CD4 lymphocytes/mm3
Measured: Day 0
Fibrosis stage
Fibroscan result
Measured: Day 0
Hepatic ultrasound
Measured: Day 0
Transaminase levels
Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase
Measured: Day 0
HIV co-infection
Yes/no
Measured: Day 0
Hepititis B co-infection
Yes/no
Measured: Day 0
Methadone treatment
Yes/no
Measured: Day 0
Access to health cover
Yes/no
Measured: Day 0
Commencement of treatment
Yes/no
Measured: Day 1
Type of treatment
Measured: Day 0
Treatment side effects
Measured: ay
Early viral response
Undetectable HCV RNA
Measured: Week 4
Sustained viral response
Undetectable HCV RNA
Measured: Week 12
HCV re-infection
Yes/no
Measured: Month 12
Risk factors associated with reinfection
Measured: 3 months after clearance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start13 Sep 2018
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Laureillard, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601546
- Sponsor's protocol ID
- NIMAO/2016-08/DL-01
- Acronym
- CoViet-C
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2018
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam
- ClinicalTrials.gov ID
- NCT03601546
- Acronym / sponsor ID
- CoViet-C / NIMAO/2016-08/DL-01
- Conditions
- Hepatitis C Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HCV infection | – | Other: Clinical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Hepititis C recruited during consultation in the infections and tropical disease service of the Viet Tiep hospital in Hai Phong, Vietnam
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinationBlood test and patient interview as for standard patient care | Other | Patients with HCV infection |
Primary outcome
Patient inclusion rate
Time frame: End of study: 12 months
Number of patients included/number of eligible patients
Rate of missing data of patient variables
Time frame: 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
Time frame: Month 6
Lost to follow-up rate
Time frame: Month 12
Archival of all signed consent forms
Time frame: End of study: Month 12
23 secondary outcomes
Social-demographic characteristics of patients at inclusion
Time frame: Day 0
drug and alcohol consumption,
Time frame: Day 0
treatment at inclusion
Time frame: Day 0
commencement of treat
Time frame: Day 1
initial HCV viral load,
Time frame: Day 0
HCV genotype
Time frame: Day 0
Fibrosis stage
Time frame: Day 0
HIV viral load
Time frame: Day 0
Lymphocyte T4 level
Time frame: Day 0
Fibrosis stage
Time frame: Day 0
Hepatic ultrasound
Time frame: Day 0
Transaminase levels
Time frame: Day 0
HIV co-infection
Time frame: Day 0
Hepititis B co-infection
Time frame: Day 0
Methadone treatment
Time frame: Day 0
Access to health cover
Time frame: Day 0
Commencement of treatment
Time frame: Day 1
Type of treatment
Time frame: Day 0
Treatment side effects
Time frame: ay
Early viral response
Time frame: Week 4
Sustained viral response
Time frame: Week 12
HCV re-infection
Time frame: Month 12
Risk factors associated with reinfection
Time frame: 3 months after clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Laureillard, MD principal investigator
CHU Nimes
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Infection, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient inclusion rate (time frame: End of study: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.