Hepatitis C Virus InfectionRelinkNCT05975216
Relinking Diagnosed But Untreated HCV Patients Back Into Care.
An observational study of Hepatitis C Virus Infection, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up. Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- Contact the patient
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jul 2023to 31 Jul 2025
- 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: Positive hepatitis C serology with positive or unknown HCV RNA.
Who may be able to join
- Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
- ≥18 years
Who cannot join
- Positive HCV serology with negative HCV RNA
- Previously eradicated patients in UZ Brussel
Trial locations and contacts
1 site in 1 country.
About this study
Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.
Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- Contact the patient
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact the patientOther
Phone call, email or letter to contact the patient to relink them.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed-but-untreated | Diagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022. Receives: Other: Contact the patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective data collection
Prevalence of diagnosed but untreated HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
Measured: before contacting the patient
Prospective interventional study
To recall DBU patients by phone, e-mail or letter, trying to optimize treated and cured patients after recall
Measured: from first contact of the patient till 12 weeks after end of treatment.
Secondary outcomes (1)
Reason lost in follow-up
Understanding the different reasons why patients were lost in follow-up with the aim of improving our hospital quality in the future:
- Unaware of positive hep C serology
- Follow-up or treatment in other centre
- Refusal of previously proposed therapy
- Other?
Measured: from first contact of the patient till 12 weeks after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start6 Jul 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus InfectionStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Other
- Time perspective
- Other
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975216
- Sponsor's protocol ID
- Relink
- Acronym
- Relink
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relinking Diagnosed But Untreated HCV Patients Back Into Care.
- ClinicalTrials.gov ID
- NCT05975216
- Acronym / sponsor ID
- Relink / Relink
- Conditions
- Hepatitis C Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 3 Aug 2023 (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.
Reintroduction of patients into a HCV infection care pathway after a positive chronic hepatitis C diagnosis by previous testing in our hospital who were lost in follow-up.
Gaining insight in the possible reasons why patients are lost in follow-up after positive hepatitis C serology.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed-but-untreated | – | Other: Contact the patientDiagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Positive hepatitis C serology with positive or unknown HCV RNA.
Key inclusion criteria (2 listed)
- Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
- ≥18 years
Key exclusion criteria (2 listed)
- Positive HCV serology with negative HCV RNA
- Previously eradicated patients in UZ Brussel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contact the patientPhone call, email or letter to contact the patient to relink them. | Other | Diagnosed-but-untreated |
Primary outcome
Retrospective data collection
Time frame: before contacting the patient
Prevalence of diagnosed but untreated HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.
Prospective interventional study
Time frame: from first contact of the patient till 12 weeks after end of treatment.
To recall DBU patients by phone, e-mail or letter, trying to optimize treated and cured patients after recall
1 secondary outcome
Reason lost in follow-up
Time frame: from first contact of the patient till 12 weeks after end of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatitis C Virus Infection, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 12 Aug 2025. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective data collection (time frame: before contacting the patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.