The Dublin Zepatier Study
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|ClinicalTrials.gov Identifier: NCT02895958|
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: Zepatier||Phase 4|
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:
- Active case finding by travelling to the services used by 'at risk' groups as opposed to giving appointments to the patient to attend hospital.
- Locating HCV patients (with positive RNA or HCV antigen) that are 'lost to follow up'.
- Staging and risk-stratifying HCV patients locally to support access to therapy.
- Educating HCV patients around new assessment tools and treatments.
- Setting up and supporting the initiation of treatment in the community e.g. daily dispensing of medication/treatment with methadone.
- Providing on-going harm reduction advice on preventing reinfection.
- Work in partnership with Methadone prescribing GP practices and Drug Treatment Centres from the North and South Dublin catchment area
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2019|
|Administration of Zepatier||
Zepatier (elbasvir and grazoprevir +/- Ribavirin) will be administered in a community setting to HCV infected G1/4 treatment naïve patients on stable opiate substitution therapy with Cirrhotic and Non-cirrhotic liver disease
- Sustained viral response (SVR) against HCV at 12 weeks after treatment [ Time Frame: 12 weeks post-treatment ]
- Sustained viral response (SVR) against HCV at 24 weeks after completion of study treatment [ Time Frame: 24 weeks post-treatment ]
- Incidence of adverse events during course of treatment [ Time Frame: Weeks 0-16 of treatment ]
- Characteristics of adverse events [ Time Frame: Week -8 pre-treatment to Week 24 post treatment ]
- Incidence of treatment discontinuation over course of treatment [ Time Frame: Weeks 0-16 of treatment ]
- Rates of premature discontinuation of drug for clinical or laboratory reasons [ Time Frame: Weeks 0-16 of treatment ]
- Evaluation of percentage relapse at 12 and 24 weeks post treatment [ Time Frame: weeks 12 and 24 post treatment ]
- Percentage of re-infection as evaluated by repeat HCV RNA positivity at weeks 12 and 24 post-treatment [ Time Frame: Weeks 12 and 24 post-treatment ]
- Safety and feasibility of model of community based integrated care with community dispensation and supervision of DAA therapy to treat 'hard to reach' HCV infected patients [ Time Frame: End of study ]
- Change of quality of life assessment questionnaire score (EQ-5D-5L) administered at baseline, 12 weeks, and 24 weeks post-treatment [ Time Frame: End of study ]
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): NCT02895958
|Contact: Jack Lambert, MD||+353 (0)firstname.lastname@example.org|
|Contact: Suzanne Barror +35317164491 email@example.com|