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Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam (CoViet-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601546
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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
Hepatitis C Infection Other: Clinical examination

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Implementing a Cohort of People Living With Hepatitis C in the Viet Tiep Hospital in Hai Phong, Vietnam
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with HCV infection Other: Clinical examination
Blood test and patient interview as for standard patient care




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
frozen plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601546


Contacts
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Contact: Didier Laureillard, MD 33.(0)04.66.68.41.49 didier.laureillard@chu-nimes.fr

Locations
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France
CHU Nimes Active, not recruiting
Nîmes, France, 30029
Vietnam
Hospital Viet Tiep Recruiting
Hai Phong, Vietnam
Contact: Vu Hai Vinh, MD    +84.(0)9.84.77.70.03    vinhvuhai@gmail.com   
Principal Investigator: Vu Hai Vinh         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Didier Laureillard, MD CHU Nimes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03601546    
Other Study ID Numbers: NIMAO/2016-08/DL-01
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections