NCT05975216

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

July 18, 2023

Last Update Submit

August 7, 2025

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    from first contact of the patient till 12 weeks after end of treatment.

Secondary Outcomes (1)

  • Reason lost in follow-up

    from first contact of the patient till 12 weeks after end of treatment.

Study Arms (1)

Diagnosed-but-untreated

Diagnosed but untreated (DBU) HCV patients through positive serology with positive or unknown HCV RNA in UZ Brussel between 2012 - 2022.

Other: Contact the patient

Interventions

Contact the patientOTHER

Phone call, email or letter to contact the patient to relink them.

Diagnosed-but-untreated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Positive hepatitis C serology with positive or unknown HCV RNA.

You may qualify if:

  • Positive HCV serology between 2012-2022 with positive or uknown HCV RNA in UZ Brussels database
  • ≥18 years

You may not qualify if:

  • Positive HCV serology with negative HCV RNA
  • Previously eradicated patients in UZ Brussel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 3, 2023

Study Start

July 6, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations

BE(1)