Chronic Hepatitis cCELINENCT04208035
Hepatitis C Elimination in the Netherlands
An observational study of Chronic Hepatitis c, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Sep 2018to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lost to follow-up (possibly) chronically HCV-infected patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6500 HB
Marleen van Dijk, MD, 0031243613999, marleen.vandijk@radboudumc.nl
About this study
Official title: Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
- Conditions
- Chronic Hepatitis c
- Medical subject headings
- Hepatitis C, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lost to follow-up (LTFU) patients successfully re-linked to care
Measured: End of study, on average 2.5 years after initiation
Secondary outcomes (10)
Total number of LTFU patients in the investigated time period
Measured: 15 years prior to study initiation
Case ascertainment rate
Established contact (via telephone or in writing) with a patient who is eligible for retrieval
Measured: 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
Measured: 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
Measured: End of study, on average 2.5 years after initiation
Number of viraemic patients at time of re-evaluation
Measured: End of study, on average 2.5 years after initiation
Liver fibrosis stage of retrieved patients
Measured: End of study, on average 2.5 years after initiation
Reasons for becoming LTFU
Measured: End of study, on average 2.5 years after initiation
Time of being LTFU
Defined as years since last (HCV-)related hospital visit
Measured: End of study, on average 2.5 years after initiation
Mode of HCV transmission
Measured: End of study, on average 2.5 years after initiation
Sustained virological response
Defined as the absence of HCV RNA at least 12 weeks after treatment
Measured: End of study, on average 2.5 years after initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start17 Sep 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Joost Drenth, Radboud University Medical Center
- Investigators
- Joost Drenth, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208035
- Sponsor's protocol ID
- 2018-4503
- Acronym
- CELINE
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32377367
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
- ClinicalTrials.gov ID
- NCT04208035
- Acronym / sponsor ID
- CELINE / 2018-4503
- Conditions
- Chronic Hepatitis c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lost to follow-up (possibly) chronically HCV-infected patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Total number of LTFU patients in the investigated time period
Time frame: 15 years prior to study initiation
Case ascertainment rate
Time frame: End of study, on average 2.5 years after initiation
Awareness of HCV diagnosis among LTFU patients
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
Time frame: End of study, on average 2.5 years after initiation
Mode of HCV transmission
Time frame: End of study, on average 2.5 years after initiation
Sustained virological response
Time frame: End of study, on average 2.5 years after initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 32377367Isfordink 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Drenth, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis c, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marleen van Dijk, MD (0034243613999, marleen.vandijk@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.