NCT02940691

Brief Summary

This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use or people receiving opioid substitution therapy and chronic HCV genotype 1 or 4 infection.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2017

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 30, 2019

Completed
Last Updated

March 9, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

October 19, 2016

Results QC Date

August 19, 2019

Last Update Submit

February 21, 2020

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)

    Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)

    12 weeks post treatment

Secondary Outcomes (2)

  • Number of Participants With Treatment Completion

    12 weeks from treatment administration

  • End of Treatment Response (Negative HCV RNA at the End of Treatment)

    12 weeks from treatment administration

Other Outcomes (1)

  • Sensitivity and Specificity of the Finger-stick Xpert® HCV Viral Load Assay for HCV RNA Detection

    12 week post treatment

Study Arms (1)

Grazoprevir/elbasvir

EXPERIMENTAL

Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.

Drug: Grazoprevir/elbasvir

Interventions

Grazoprevir/elbasvirDRUG

Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.

Also known as: Zepatier
Grazoprevir/elbasvir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants have voluntarily signed the informed consent form.
  • Be ≥18 years of age on day of signing informed consent form.
  • Have chronic HCV genotype 1 or 4 infection (defined as detectable HCV RNA).
  • Recent injecting drug use (previous 6 months) or receiving opioid substitution therapy.
  • HIV-1 infected subjects enrolled in the study must meet the following criteria:
  • Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load
  • b) Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the intended DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/) or current prescribing guidelines for elbasvir/grazoprevir OR be naive to treatment with any antiretroviral therapy (ART) with a baseline CD4 count of \>200 and have no plans to initiate ART treatment while participating in this study and through to at least Follow-up Week 4.
  • Negative pregnancy test at screening and baseline (females of childbearing potential only).
  • All fertile males and females must be using effective contraception during treatment and during 14 days after treatment end.

You may not qualify if:

  • Is taking or plans to take any prohibited medications as per DAA Product Information or herbal supplements, including but not limited to St. John's Wort (Hypericum perforatum) within 2 weeks of Baseline.
  • Is currently using or intends to use barbiturates.
  • Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Baseline and continue throughout treatment, and after the last dose of study medication (as per the regimen requirements), or longer if dictated by local regulations.
  • Has any condition or pre-study laboratory abnormality, ECG abnormality or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the subject.
  • Had a life-threatening SAE during the screening period.
  • Haemoglobin \< 9.5 g/dL for both males and females
  • Platelets \< 50 x 10\^3 /µL
  • Serum albumin \< 3.0 g/dL
  • Patients with Child Pugh-B or C decompensated cirrhosis
  • Previous HCV treatment-experience.
  • Ongoing severe psychiatric disease as judged by the treating physician.
  • Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
  • Is Hepatitis B surface antigen (HBsAg) positive
  • NOTE: Sanger sequencing will be performed on a pre-treatment sample on all participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kirketon Road Centre

Darlinghurst, New South Wales, 2010, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

The Langton Centre

Darlinghurst, New South Wales, 2010, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

Drug and Alcohol Clinical Services (Hunter)

Newcastle, New South Wales, 2300, Australia

Location

Related Publications (1)

  • Grebely J, Read P, Cunningham EB, Weltman M, Matthews GV, Dunlop A, Montebello M, Martinello M, Gilliver R, Marks P, Applegate TL, Dore GJ; DARLO-C Study Group. Elbasvir and grazoprevir for hepatitis C virus genotype 1 infection in people with recent injecting drug use (DARLO-C): An open-label, single-arm, phase 4, multicentre trial. Health Sci Rep. 2020 Mar 15;3(2):e151. doi: 10.1002/hsr2.151. eCollection 2020 Jun.

    PMID: 32270056DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Professor Jason Grebely
Organization
Kirby Institute
jgrebely@kirby.unsw.edu.au
+61 2 9385 0957

Study Officials

  • Greg Dore, MBBS

    Kirby Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

May 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 9, 2020

Results First Posted

December 30, 2019

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(5)