Hepatitis CPhase 4NCT02895958
The Dublin Zepatier Study
A Phase 4 study testing Zepatier in people with Hepatitis C, run by Mater Misericordiae University Hospital at 1 site in Ireland.
Trial summary
Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Zepatier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIreland
- Study dates
- 15 Mar 2018to 6 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥18 years of age.
- Subject must be HCV treatment naive. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
- Documented chronic HCV infection (RNA positive), HCV RNA levels > 10x4 IU/ml.
- Documented HCV genotype 1 and 4.
- Documented HIV and HBV uninfected (HIV Ab negative, HBsAg negative)
- A female is eligible to enter and participate in the study if she is of:
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- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
- Child-bearing potential, has a negative pregnancy test (serum β-HCG) at screen and agrees to an acceptable barrier and/or hormonal method of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician): Sterilization (female subject or male partner of female subject). Male and female subjects must agree to 7 months post-treatment contraception if taking ribavirin and one month post- treatment contraception for Zepatier only.
- Stable attender in the site of enrolment (receiving OST at least 3 months before enrolment and were at least 80 % adherent to OST appointments)
- Venous access available for blood monitoring.
- Fibroscan done as per HSE Hepatitis C Advisory Group guidelines.
- Safety bloods done prior to study including a HGB > 9.5g/dL, platelets > 75,000, AST < 10x ULN, albumin levels > 30g/L.
Who cannot join
- 1. Child Pugh B or C (see Appendix 10.1 for Child-Pugh Classification)
- HCV non-G1/G4
- History of decompensated liver disease
- Laboratory exclusions include platelet count <75,000, albumin <30gm/L, Alanine aminotransferase (ALT) >10 times the upper limit of normal (ULN).
- Subject is enrolled in one or more investigational drug protocols, which may impact on assessment of HCV treatment with Zepatier (+/-ribavirin).
- Subject is, in the opinion of the investigator, unable to complete the study dosing period and protocol evaluations and assessments.
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- Patients with alcohol and drug use problems that in the view of investigator will compromise adherence to compliance with the study will be excluded.
- Subject is either pregnant or breastfeeding.
- Subject suffers from any serious medical condition (such as pancreatitis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction), which in the opinion of the Investigator, would compromise the safety of the subject.
- Subject has a pre-existing mental, physical, or substance abuse disorder that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
- Subject has a history of inflammatory bowel disease or intestinal malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which, in the opinion of the Investigator, may interfere with drug absorption or render the subject unable to take oral medication.
- Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the 45-day screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
- Subject has received treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
- Subjects who require treatment with any contraindicated medications (as outlined in the SPC) within 14 days of commencement of investigational product, or an anticipated need during the study.
- Subject has a history of allergy to any of the treatment products or any excipients therein.
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy.
Read the 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:
- 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
- Conditions
- Hepatitis C
- Being tested
- Zepatier
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZepatierDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Administration of Zepatier | Other | Not described Receives: Drug: Zepatier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response (SVR) against HCV at 12 weeks after treatment
Measured: 12 weeks post-treatment
Secondary outcomes (9)
Sustained viral response (SVR) against HCV at 24 weeks after completion of study treatment
Measured: 24 weeks post-treatment
Incidence of adverse events during course of treatment
Measured: Weeks 0-16 of treatment
Characteristics of adverse events
Measured: Week -8 pre-treatment to Week 24 post treatment
Incidence of treatment discontinuation over course of treatment
Measured: Weeks 0-16 of treatment
Rates of premature discontinuation of drug for clinical or laboratory reasons
Measured: Weeks 0-16 of treatment
Evaluation of percentage relapse at 12 and 24 weeks post treatment
Measured: weeks 12 and 24 post treatment
Percentage of re-infection as evaluated by repeat HCV RNA positivity at weeks 12 and 24 post-treatment
Measured: 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
Measured: End of study
Change of quality of life assessment questionnaire score (EQ-5D-5L) administered at baseline, 12 weeks, and 24 weeks post-treatment
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start15 Mar 2018
- Primary completion23 May 2019
- Study completion6 Dec 2019
Why it stopped: Insufficient study participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mater Misericordiae University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Dr. Jack Lambert, Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895958
- Sponsor's protocol ID
- ZEP-HEPC-001
- Status last verified
- Dec 2019
- First submitted
- 30 Aug 2016
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02895958
- Acronym / sponsor ID
- ZEP-HEPC-001
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient study participants enrolled
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mater Misericordiae University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Zepatier | Other | Drug: Zepatier |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥18 years of age.
- Subject must be HCV treatment naive. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
- Documented chronic HCV infection (RNA positive), HCV RNA levels > 10x4 IU/ml.
- Documented HCV genotype 1 and 4.
- Documented HIV and HBV uninfected (HIV Ab negative, HBsAg negative)
Key exclusion criteria (15 listed)
- 1. Child Pugh B or C (see Appendix 10.1 for Child-Pugh Classification)
- HCV non-G1/G4
- History of decompensated liver disease
- Laboratory exclusions include platelet count <75,000, albumin <30gm/L, Alanine aminotransferase (ALT) >10 times the upper limit of normal (ULN).
- Subject is enrolled in one or more investigational drug protocols, which may impact on assessment of HCV treatment with Zepatier (+/-ribavirin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZepatierZepatier (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 | Drug | Administration of Zepatier |
Primary outcome
Sustained viral response (SVR) against HCV at 12 weeks after treatment
Time frame: 12 weeks post-treatment
9 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Insufficient study participants enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zepatier in people with Hepatitis C, run by Mater Misericordiae University Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient study participants enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained viral response (SVR) against HCV at 12 weeks after treatment (time frame: 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.