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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088917
Recruitment Status : Completed
First Posted : March 23, 2017
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Joost Drenth, Radboud University Medical Center

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of all patients, that in the past have been identified at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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


Condition or disease
Chronic Hepatitis c

Study Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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that in the past have been diagnosed with hepatitis C at the Radboudumc but who are currently lost to or have been withdrawn from follow-up.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.


Outcome Measures
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Primary Outcome Measures :
  1. Liver Fibrosis Stage [ Time Frame: 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 :
  1. Reasons for Loss to Follow-up [ Time Frame: Baseline ]
    through chart review or questioning screening event

  2. Genotype Distribution [ Time Frame: Baseline ]
    Genotype distribution among RNA-positive patients

  3. Fibrosis Progression [ Time Frame: 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.

  4. Treatment Outcome [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
blood serum samples will be saved in the biobank after participation

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088917


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Joost Drenth, Md,PhD,Prof Radboud University Medical Center
  Study Documents (Full-Text)

Documents provided by Joost Drenth, Radboud University Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 10, 2017

More Information
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Responsible Party: Joost Drenth, Professor, MD, PhD, Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT03088917    
Other Study ID Numbers: 2017-3198
First Posted: March 23, 2017    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Possibly individual data on primary and secondary outcomes can be requested from reserachers or shared via digital research environment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections