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

NCT03088917 | Completed Results

• 1 other identifier: 2017-3198
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reasons for Loss to Follow-up

  Baseline

• Genotype Distribution

  Baseline

• Fibrosis Progression

  Baseline

• Treatment Outcome

  At least 12 weeks after end of treatment

Study Arms (1)

lost to follow-up patients

This so-called lost population consists of all patients, that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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 diagnosed with hepatitis C 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood serum samples will be saved in the biobank after participation

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. dr. J.P.H. Drenth
• Organization: Radboudumc

joost.drenth@radboudumc.nl

0031243613999

Study Officials

• Joost Drenth, Md,PhD,Prof

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 23, 2017
• Study Start: September 27, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Locations

NL (1)