The Dublin Zepatier Study

December 6, 2019 updated by: Dr. Jack Lambert, Mater Misericordiae University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Thompson Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is ≥18 years of age.
  2. Subject must be HCV treatment naive. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
  3. Documented chronic HCV infection (RNA positive), HCV RNA levels > 10x4 IU/ml.
  4. Documented HCV genotype 1 and 4.
  5. Documented HIV and HBV uninfected (HIV Ab negative, HBsAg negative)

  6. A female is eligible to enter and participate in the study if she is of:

    • 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.
  7. Stable attender in the site of enrolment (receiving OST at least 3 months before enrolment and were at least 80 % adherent to OST appointments)
  8. Venous access available for blood monitoring.
  9. Fibroscan done as per HSE Hepatitis C Advisory Group guidelines.
  10. Safety bloods done prior to study including a HGB > 9.5g/dL, platelets > 75,000, AST < 10x ULN, albumin levels > 30g/L.

Exclusion Criteria:

  1. 1. Child Pugh B or C (see Appendix 10.1 for Child-Pugh Classification)
  2. HCV non-G1/G4
  3. History of decompensated liver disease
  4. Laboratory exclusions include platelet count <75,000, albumin <30gm/L, Alanine aminotransferase (ALT) >10 times the upper limit of normal (ULN).
  5. Subject is enrolled in one or more investigational drug protocols, which may impact on assessment of HCV treatment with Zepatier (+/-ribavirin).
  6. Subject is, in the opinion of the investigator, unable to complete the study dosing period and protocol evaluations and assessments.
  7. Patients with alcohol and drug use problems that in the view of investigator will compromise adherence to compliance with the study will be excluded.
  8. Subject is either pregnant or breastfeeding.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Subject has a history of allergy to any of the treatment products or any excipients therein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Administration of Zepatier
Drug: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sustained viral response (SVR) against HCV at 12 weeks after treatment
Time Frame: 12 weeks post-treatment
12 weeks post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Sustained viral response (SVR) against HCV at 24 weeks after completion of study treatment
Time Frame: 24 weeks post-treatment
24 weeks post-treatment
Incidence of adverse events during course of treatment
Time Frame: Weeks 0-16 of treatment
Weeks 0-16 of treatment
Characteristics of adverse events
Time Frame: Week -8 pre-treatment to Week 24 post treatment
Week -8 pre-treatment to Week 24 post treatment
Incidence of treatment discontinuation over course of treatment
Time Frame: Weeks 0-16 of treatment
Weeks 0-16 of treatment
Rates of premature discontinuation of drug for clinical or laboratory reasons
Time Frame: Weeks 0-16 of treatment
Weeks 0-16 of treatment
Evaluation of percentage relapse at 12 and 24 weeks post treatment
Time Frame: weeks 12 and 24 post treatment
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
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
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
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mater Misericordiae University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZEP-HEPC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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