Clinical trial NCT04208035: Hepatitis C Elimination in the Netherlands
Official title: Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis c
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-12-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lost to follow-up (possibly) chronically HCV-infected patients

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of lost to follow-up (LTFU) patients successfully re-linked to care
timeFrame: End of study, on average 2.5 years after initiation
Secondary outcomes:
measure: Total number of LTFU patients in the investigated time period
timeFrame: 15 years prior to study initiation
measure: Case ascertainment rate
timeFrame: End of study, on average 2.5 years after initiation
measure: Awareness of HCV diagnosis among LTFU patients
timeFrame: End of study, on average 2.5 years after initiation
measure: Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test
timeFrame: End of study, on average 2.5 years after initiation
measure: Number of viraemic patients at time of re-evaluation
timeFrame: End of study, on average 2.5 years after initiation
measure: Liver fibrosis stage of retrieved patients
timeFrame: End of study, on average 2.5 years after initiation
measure: Reasons for becoming LTFU
timeFrame: End of study, on average 2.5 years after initiation
measure: Time of being LTFU
timeFrame: End of study, on average 2.5 years after initiation
measure: Mode of HCV transmission
timeFrame: End of study, on average 2.5 years after initiation
measure: Sustained virological response
timeFrame: End of study, on average 2.5 years after initiation
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Joost Drenth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.