'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'

Completed

• Conditions: Chronic Hepatitis c

• Registration Number: NCT03088917
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Objective:

To coordinate active tracing of chronic hepatitis C patients lost to follow-up to inform them about there disease severity and treatment options.

Study design: This is a prospective cohort study, which will start as a pilot study in the Radboudumc Population: lost to follow-up chronic hepatitis C patients in the region Nijmegen. This so-called lost population consists of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up. The time-span of interest will be 2000-2015. We estimate that this project will retrace 100 lost patients through this search.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-23
• Study Start: 2017-09-27
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Results First Submitted: 2019-12-06
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-04
• Last Update Submitted: 2020-02-04
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• ever diagnosed with hepatitis C, lost to follow-up

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver Fibrosis Stage	Baseline	Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness \<7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness \>9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome.

Secondary Outcome Measures

Name	Time	Method
Genotype Distribution	Baseline	Genotype distribution among RNA-positive patients
Treatment Outcome	At least 12 weeks after end of treatment	Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment
Fibrosis Progression	Baseline	Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation.
Reasons for Loss to Follow-up	Baseline	through chart review or questioning screening event

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands