The Dublin Zepatier Study

NCT02895958 | Terminated Phase 4

• 1 other identifier: ZEP-HEPC-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained viral response (SVR) against HCV at 12 weeks after treatment

  12 weeks post-treatment

Secondary Outcomes (9)

• Sustained viral response (SVR) against HCV at 24 weeks after completion of study treatment

  24 weeks post-treatment

• Incidence of adverse events during course of treatment

  Weeks 0-16 of treatment

• Characteristics of adverse events

  Week -8 pre-treatment to Week 24 post treatment

• Incidence of treatment discontinuation over course of treatment

  Weeks 0-16 of treatment

• Rates of premature discontinuation of drug for clinical or laboratory reasons

  Weeks 0-16 of treatment

Study Arms (1)

Administration of Zepatier

OTHER

Drug: Zepatier

Interventions

Zepatier DRUG

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

Administration of Zepatier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• \. Child Pugh B or C (see Appendix 10.1 for Child-Pugh Classification)
• HCV non-G1/G4
• History of decompensated liver disease
• 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.
• 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.

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Thompson Centre

Dublin, Ireland

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infectious Diseases Consultant

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 12, 2016
• Study Start: March 15, 2018
• Primary Completion: May 23, 2019
• Study Completion: December 6, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

IE (1)