The Dublin Zepatier Study

Status Terminated

Clinical Trial Summary

Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy.

Clinical Trial Description

Hard-to-reach groups such as those attending addiction and homeless services are particularly at risk for HCV-associated liver disease progression as they do not engage in treatment, have poor attendance records for appointments, and are at risk of progression to cirrhosis without evaluation and detection. These patients are therefore "silently" progressing in the community and may be close to decompensation. Once a patient goes over that critical stage from compensated to decompensated cirrhosis, the cost to the patient in terms of their health, and the cost to the state in terms of the management of cirrhosis related complications are great.

As part of this investigator-led community-based treatment protocol we aim to demonstrate the utility of an integrated community-based care partnership between primary and secondary care to best evaluate and treat such hard to reach populations.

We aim to actively find fibrosis levels of HCV related liver disease using the FibroScan diagnostic tool, and support patients to be treated for their HCV with the newly available DAAs and be cured of their HCV infection and disease through:

1. Active case finding by travelling to the services used by 'at risk' groups as opposed to giving appointments to the patient to attend hospital.

2. Locating HCV patients (with positive RNA or HCV antigen) that are 'lost to follow up'.

3. Staging and risk-stratifying HCV patients locally to support access to therapy.

4. Educating HCV patients around new assessment tools and treatments.

5. Setting up and supporting the initiation of treatment in the community e.g. daily dispensing of medication/treatment with methadone.

6. Providing on-going harm reduction advice on preventing reinfection.

7. Work in partnership with Methadone prescribing GP practices and Drug Treatment Centres from the North and South Dublin catchment area ;

Study Design

Related Conditions & MeSH terms

Hepatitis C

Clinical Trial Details

NCT number	NCT02895958
Study type	Interventional
Source	Mater Misericordiae University Hospital
Contact
Status	Terminated
Phase	Phase 4
Start date	March 15, 2018
Completion date	December 6, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.