NCT04208035 - Hepatitis C Elimination in the Netherlands | Crick | Crick

Hepatitis C Elimination in the Netherlands

N/AUnknownNCT04208035

Radboud University Medical Center250 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Chronic Hepatitis c

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

Total number of LTFU patients in the investigated time period

Time frame: 15 years prior to study initiation

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

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

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

Number of viraemic patients at time of re-evaluation

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

Liver fibrosis stage of retrieved patients

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

Reasons for becoming LTFU

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

Time of being LTFU

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

Central Contacts

Marleen van Dijk, MD

CONTACT

0034243613999 marleen.vandijk@radboudumc.nl

Data from ClinicalTrials.gov

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