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Status unknownNCT04208035CELINEUpdated Dec 23, 2019

Hepatitis C Elimination in the Netherlands

An observational study in Chronic Hepatitis c, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-23.

Sponsored by Radboud University Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Hepatitis c
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 250 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Lost to follow-up (possibly) chronically HCV-infected patients

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
250 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of lost to follow-up (LTFU) patients successfully re-linked to care

    Time frame: End of study, on average 2.5 years after initiation

Secondary outcomes

  1. Total number of LTFU patients in the investigated time period

    Time frame: 15 years prior to study initiation

  2. Case ascertainment rate

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

    Time frame: End of study, on average 2.5 years after initiation

  3. Awareness of HCV diagnosis among LTFU patients

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

    Time frame: End of study, on average 2.5 years after initiation

  4. Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test

    Time frame: End of study, on average 2.5 years after initiation

  5. Number of viraemic patients at time of re-evaluation

    Time frame: End of study, on average 2.5 years after initiation

  6. Liver fibrosis stage of retrieved patients

    Time frame: End of study, on average 2.5 years after initiation

  7. Reasons for becoming LTFU

    Time frame: End of study, on average 2.5 years after initiation

  8. Time of being LTFU

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

    Time frame: End of study, on average 2.5 years after initiation

  9. Mode of HCV transmission

    Time frame: End of study, on average 2.5 years after initiation

  10. Sustained virological response

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

    Time frame: End of study, on average 2.5 years after initiation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Isfordink CJ, Brakenhoff SM, van Dijk M, van der Valk M, de Knegt RJ, Arends JE, Drenth JP; HepNed study group. Hepatitis C elimination in the Netherlands (CELINE): study protocol for nationwide retrieval of lost to follow-up patients with chronic hepatitis C. BMJ Open Gastroenterol. 2020 Apr 12;7(1):e000396. doi: 10.1136/bmjgast-2020-000396. eCollection 2020. PubMed 32377367 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04208035
Lead sponsor
Radboud University Medical Center
Collaborators
Gilead Sciences
Responsible party
Joost Drenth (Professor, MD, PhD, Radboud University Medical Center) — Principal investigator
First posted
Dec 23, 2019
Start date
Sep 17, 2018
Primary completion
Jan 1, 2021 (estimated)
Completion
Jan 1, 2021 (estimated)
Last update
Dec 23, 2019

Study contacts

Marleen van Dijk, MD
Contact
marleen.vandijk@radboudumc.nl
0034243613999
Joost Drenth, MD, PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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