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

Chronic Hepatitis c Clinical Trial

— Track&Trace  

Official title:

'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat' A Prospective Cohort Study Assessing the Impact of Loss to Follow-up on Liver Fibrosis in Chronic Hepatitis C.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088917
• Other study ID #: 2017-3198
• Status: Completed
• Start date: September 27, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Fibrosis Stage	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.	Baseline
Secondary	Reasons for Loss to Follow-up	through chart review or questioning screening event	Baseline
Secondary	Genotype Distribution	Genotype distribution among RNA-positive patients	Baseline
Secondary	Fibrosis Progression	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.	Baseline
Secondary	Treatment Outcome	Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment	At least 12 weeks after end of treatment