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Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs (DARLO-C)

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ClinicalTrials.gov Identifier: NCT02940691
Recruitment Status : Terminated (Poor recruitment. New treatments became available with same or shorter duration.)
First Posted : October 21, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

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 and chronic HCV genotype 1 or 4 infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Grazoprevir/elbasvir Phase 4

Detailed Description:

A prospective, observational cohort design will be used to enrol patients attending tertiary, drug and alcohol and primary health care services in Sydney, Australia.

The study consists of a treatment phase (12 weeks) and a follow-up phase (up to 3 years) where participants will be followed every 3 months for the first year and every 6 months in years 2-3 to evaluate treatment response and reinfection.

The effectiveness of the treatment will be assessed by looking at the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following therapy with grazoprevir/elbasvir and evaluate demographic and clinical predictors of non-response.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Open-label, Single Arm, Multicentre Trial of Grazoprevir/Elbasvir for Genotype 1 or 4 in People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Grazoprevir/elbasvir
Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks.
Drug: Grazoprevir/elbasvir
Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
Other Name: Zepatier




Primary Outcome Measures :
  1. The proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following interferon-free and ribavirin-free DAA therapy with grazoprevir/elbasvir among PWID with recent injecting drug use and chronic HCV genotype 1 or 4. [ Time Frame: 12 weeks post treatment ]

Secondary Outcome Measures :
  1. To evaluate the rate of HCV reinfection up to three years following interferon-free and ribavirin-free DAA therapy with grazoprevir/elbasvir. [ Time Frame: 3 year post treatment commencement ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants have voluntarily signed the informed consent form.
  • Be ≥18 years of age on day of signing informed consent form.
  • Have HCV infection as documented by detectable HCV RNA.
  • Have HCV genotype 1 or 4 infection.
  • Recent injecting drug use (previous 6 months).
  • 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
    • Be naive to treatment with any antiretroviral therapy (ART) (and have no plans to initiate ART treatment while participating in this study and through at least Follow-up Week 4 OR 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 grazoprevir/elbasvir.
  • 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.

Exclusion Criteria:

  • 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.
  • Has exclusionary laboratory values as listed below:

    • Haemoglobin < 9.5 g/dL for both males and females
    • Platelets < 50 x 103 /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.

Information from the National Library of Medicine

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): NCT02940691


Locations
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Australia, New South Wales
Kirketon Road Centre
Darlinghurst, New South Wales, Australia, 2010
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
The Langton Centre
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital
Kingswood, New South Wales, Australia, 2751
Drug and Alcohol Clinical Services (Hunter)
Newcastle, New South Wales, Australia, 2300
Sponsors and Collaborators
Kirby Institute
Investigators
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Principal Investigator: Greg Dore, MBBS Kirby Institute

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02940691     History of Changes
Other Study ID Numbers: VHCRP1510
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
MK-5172
Antiviral Agents
Anti-Infective Agents