Feasibility of Implementing a Cohort of People Living Wit... | NCT03601546

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

NCT03601546

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Last Update Posted

Jun 17, 2026Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Hepatitis C Infection

Interventions

Clinical examination

Countries

France
Vietnam

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2018Actual

Primary Completion Date

Nov 3, 2021Actual

Completion Date

Nov 3, 2021Actual

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with HCV infection			Other: Clinical examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical examination	Other	Blood test and patient interview as for standard patient care	Patients with HCV infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Social-demographic characteristics of patients at inclusion	age, sex, weight, height, pregnancy test,	Day 0
drug and alcohol consumption,	type and amount

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Didier Laureillard, MD	CHU Nimes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Nimes		Nîmes		30029	France
Hospital Viet Tiep

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided