Hepatitis C Elimination in the Netherlands

Chronic Hepatitis c Clinical Trial

— CELINE  

Official title:

Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208035
• Other study ID #: 2018-4503
• Status: Recruiting
• Start date: September 17, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2019
• Source: Radboud University
• Contact: Marleen van Dijk, MD
• Phone: 0034243613999
• Email: marleen.vandijk[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Gilead Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lost to follow-up (LTFU) patients successfully re-linked to care		End of study, on average 2.5 years after initiation
Secondary	Total number of LTFU patients in the investigated time period		15 years prior to study initiation
Secondary	Case ascertainment rate	Established contact (via telephone or in writing) with a patient who is eligible for retrieval	End of study, on average 2.5 years after initiation
Secondary	Awareness of HCV diagnosis among LTFU patients	Number of patients who were aware of their HCV diagnosis when they are invited for re-evaluation	End of study, on average 2.5 years after initiation
Secondary	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
Secondary	Number of viraemic patients at time of re-evaluation		End of study, on average 2.5 years after initiation
Secondary	Liver fibrosis stage of retrieved patients		End of study, on average 2.5 years after initiation
Secondary	Reasons for becoming LTFU		End of study, on average 2.5 years after initiation
Secondary	Time of being LTFU	Defined as years since last (HCV-)related hospital visit	End of study, on average 2.5 years after initiation
Secondary	Mode of HCV transmission		End of study, on average 2.5 years after initiation
Secondary	Sustained virological response	Defined as the absence of HCV RNA at least 12 weeks after treatment	End of study, on average 2.5 years after initiation