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Completed

NCT Number: NCT03601546

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

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes, Nîmes, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Clinical examination

Other

Blood test and patient interview as for standard patient care

Primary outcomes

  1. Patient inclusion rate

    Time frame: End of study: 12 months

    Number of patients included/number of eligible patients

  2. 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,

  3. Lost to follow-up rate

    Time frame: Month 6

  4. Lost to follow-up rate

    Time frame: Month 12

  5. Archival of all signed consent forms

    Time frame: End of study: Month 12

Secondary outcomes

  1. Social-demographic characteristics of patients at inclusion

    Time frame: Day 0

    age, sex, weight, height, pregnancy test,

  2. drug and alcohol consumption,

    Time frame: Day 0

    type and amount

  3. treatment at inclusion

    Time frame: Day 0

  4. commencement of treat

    Time frame: Day 1

  5. initial HCV viral load,

    Time frame: Day 0

    UI/ml

  6. HCV genotype

    Time frame: Day 0

  7. Fibrosis stage

    Time frame: Day 0

  8. HIV viral load

    Time frame: Day 0

    Copies/ml

  9. Lymphocyte T4 level

    Time frame: Day 0

    Number of CD4 lymphocytes/mm3

  10. Fibrosis stage

    Time frame: Day 0

    Fibroscan result

  11. Hepatic ultrasound

    Time frame: Day 0

  12. Transaminase levels

    Time frame: Day 0

    Gamma-glutamyl transferase, Aspartate amino transferase, Alanine amino transferase

  13. HIV co-infection

    Time frame: Day 0

    Yes/no

  14. Hepititis B co-infection

    Time frame: Day 0

    Yes/no

  15. Methadone treatment

    Time frame: Day 0

    Yes/no

  16. Access to health cover

    Time frame: Day 0

    Yes/no

  17. Commencement of treatment

    Time frame: Day 1

    Yes/no

  18. Type of treatment

    Time frame: Day 0

  19. Treatment side effects

    Time frame: ay

  20. Early viral response

    Time frame: Week 4

    Undetectable HCV RNA

  21. Sustained viral response

    Time frame: Week 12

    Undetectable HCV RNA

  22. HCV re-infection

    Time frame: Month 12

    Yes/no

  23. Risk factors associated with reinfection

    Time frame: 3 months after clearance

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam

Acronym: CoViet-C

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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