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Hepatitis C Elimination in the Netherlands (CELINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208035
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Joost Drenth, Radboud University

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

Condition or disease
Chronic Hepatitis c

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Total number of LTFU patients in the investigated time period [ Time Frame: 15 years prior to study initiation ]
  2. Case ascertainment rate [ Time Frame: 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

  3. Awareness of HCV diagnosis among LTFU patients [ Time Frame: 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

  4. 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 ]
  5. Number of viraemic patients at time of re-evaluation [ Time Frame: End of study, on average 2.5 years after initiation ]
  6. Liver fibrosis stage of retrieved patients [ Time Frame: End of study, on average 2.5 years after initiation ]
  7. Reasons for becoming LTFU [ Time Frame: End of study, on average 2.5 years after initiation ]
  8. Time of being LTFU [ Time Frame: End of study, on average 2.5 years after initiation ]
    Defined as years since last (HCV-)related hospital visit

  9. Mode of HCV transmission [ Time Frame: End of study, on average 2.5 years after initiation ]
  10. Sustained virological response [ Time Frame: End of study, on average 2.5 years after initiation ]
    Defined as the absence of HCV RNA at least 12 weeks after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lost to follow-up (possibly) chronically HCV-infected patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208035


Contacts
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Contact: Marleen van Dijk, MD 0034243613999 marleen.vandijk@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Marleen van Dijk, MD    0031243613999    marleen.vandijk@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Gilead Sciences
Investigators
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Principal Investigator: Joost Drenth, MD, PhD Radboud University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joost Drenth, Professor, MD, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT04208035    
Other Study ID Numbers: 2018-4503
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections