Hepatitis C Elimination in the Netherlands
- Conditions
- Chronic Hepatitis c
- Registration Number
- NCT04208035
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Time of being LTFU End of study, on average 2.5 years after initiation Defined as years since last (HCV-)related hospital visit
Reasons for becoming LTFU End of study, on average 2.5 years after initiation Liver fibrosis stage of retrieved patients End of study, on average 2.5 years after initiation 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 Established contact (via telephone or in writing) with a patient who is eligible for retrieval
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
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 Mode of HCV transmission End of study, on average 2.5 years after initiation 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
Trial Locations
- Locations (1)
Radboudumc
🇳🇱Nijmegen, Gelderland, Netherlands