Hepatitis C Elimination in the Netherlands
CELINE
1 other identifier
observational
250
1 country
1
Brief Summary
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2018
CompletedFirst Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedDecember 23, 2019
December 1, 2019
2.3 years
December 6, 2019
December 18, 2019
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (10)
Total number of LTFU patients in the investigated time period
15 years prior to study initiation
Case ascertainment rate
End of study, on average 2.5 years after initiation
Awareness of HCV diagnosis among LTFU patients
End of study, on average 2.5 years after initiation
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
Number of viraemic patients at time of re-evaluation
End of study, on average 2.5 years after initiation
- +5 more secondary outcomes
Eligibility Criteria
Lost to follow-up (possibly) chronically HCV-infected patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Gilead Sciencescollaborator
Study Sites (1)
Radboudumc
Nijmegen, Gelderland, 6500 HB, Netherlands
Related Publications (1)
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.
PMID: 32377367DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joost Drenth, MD, PhD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 23, 2019
Study Start
September 17, 2018
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
December 23, 2019
Record last verified: 2019-12