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CELINE: Hepatitis C Elimination in the Netherlands

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04208035
Collaborator
Gilead Sciences (Industry)
250
Enrollment
1
Location
27.5
Anticipated Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
    Actual Study Start Date :
    Sep 17, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Number of lost to follow-up (LTFU) patients successfully re-linked to care [End of study, on average 2.5 years after initiation]

    Secondary Outcome Measures

    1. Total number of LTFU patients in the investigated time period [15 years prior to study initiation]

    2. Case ascertainment rate [End of study, on average 2.5 years after initiation]

      Established contact (via telephone or in writing) with a patient who is eligible for retrieval

    3. Awareness of HCV diagnosis among LTFU patients [End of study, on average 2.5 years after initiation]

      Number of patients who were aware of their HCV diagnosis when they are invited for re-evaluation

    4. Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test [End of study, on average 2.5 years after initiation]

    5. Number of viraemic patients at time of re-evaluation [End of study, on average 2.5 years after initiation]

    6. Liver fibrosis stage of retrieved patients [End of study, on average 2.5 years after initiation]

    7. Reasons for becoming LTFU [End of study, on average 2.5 years after initiation]

    8. Time of being LTFU [End of study, on average 2.5 years after initiation]

      Defined as years since last (HCV-)related hospital visit

    9. Mode of HCV transmission [End of study, on average 2.5 years after initiation]

    10. Sustained virological response [End of study, on average 2.5 years after initiation]

      Defined as the absence of HCV RNA at least 12 weeks after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test

    • Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result

    Exclusion Criteria:

    • Younger than 18

    • Deceased

    • Not residing in the Netherlands

    • Unknown current address

    • Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Gelderland Netherlands 6500 HB

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Gilead Sciences

    Investigators

    • Principal Investigator: Joost Drenth, MD, PhD, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joost Drenth, Professor, MD, PhD, Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04208035
    Other Study ID Numbers:
    • 2018-4503
    First Posted:
    Dec 23, 2019
    Last Update Posted:
    Dec 23, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Dec 23, 2019