Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT02895958
Status:
TERMINATED
Last Update Posted:
2019-12-10
First Post:
2016-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dublin Zepatier Study
Sponsor:
Mater Misericordiae University Hospital
Organization:
Study Overview
Official Title:
Open Label Study of the Safety and Efficacy of FDC Zepatier (Elbasvir+Grazoprevir +/- Ribavirin)Administered in a Community Based Setting to HCV Infected G1/4 Treatment naïve Patients on Stable Opiate Substitution Therapy With Cirrhotic and Non-cirrhotic Liver Disease
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient study participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy.
Detailed 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: