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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940691
Recruitment Status : Terminated (Poor recruitment due to new treatments becoming available.)
First Posted : October 21, 2016
Results First Posted : December 30, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Study Description
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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.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
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 or Receiving Opioid Substitution Therapy
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


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) [ Time Frame: 12 weeks post treatment ]
    Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)


Secondary Outcome Measures :
  1. Number of Participants With Treatment Completion [ Time Frame: 12 weeks from treatment administration ]
    Number who completed HCV treatment as prescribed (12 weeks of grazoprevir/elbasvir (100mg/50mg) daily)

  2. End of Treatment Response (Negative HCV RNA at the End of Treatment) [ Time Frame: 12 weeks from treatment administration ]
    Number with undetectable HCV RNA at end of treatment following 12 weeks of daily Grazoprevir/Elbasvir (100mg/50mg)


Other Outcome Measures:
  1. Sensitivity and Specificity of the Finger-stick Xpert® HCV Viral Load Assay for HCV RNA Detection [ Time Frame: 12 week post treatment ]
    To determine the sensitivity and specificity of the Xpert® HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick capillary whole-blood.


Eligibility Criteria
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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 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.

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 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.

Contacts and Locations
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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
  Study Documents (Full-Text)

Documents provided by Kirby Institute:
Study Protocol and Statistical Analysis Plan  [PDF] December 12, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT02940691    
Other Study ID Numbers: VHCRP1510
First Posted: October 21, 2016    Key Record Dates
Results First Posted: December 30, 2019
Last Update Posted: March 9, 2020
Last Verified: February 2020
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 A
Hepatitis C
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Grazoprevir
Antiviral Agents
Anti-Infective Agents