Hepatitis CPhase 4DARLO-CNCT02940691
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
A Phase 4 study testing Grazoprevir/elbasvir in people with Hepatitis C, run by Kirby Institute at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Grazoprevir/elbasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesAustralia
- Study dates
- 1 May 2017to 1 Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Kirketon Road Centre
Darlinghurst, New South Wales, 2010
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
The Langton Centre
Darlinghurst, New South Wales, 2010
Nepean Hospital
Kingswood, New South Wales, 2751
Drug and Alcohol Clinical Services (Hunter)
Newcastle, New South Wales, 2300
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Grazoprevir/elbasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazoprevir/elbasvirDrug
Also called Zepatier
Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grazoprevir/elbasvir | Experimental | Grazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks. Receives: Drug: Grazoprevir/elbasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks post treatment
Secondary outcomes (2)
Number of Participants With Treatment Completion
Number who completed HCV treatment as prescribed (12 weeks of grazoprevir/elbasvir (100mg/50mg) daily)
Measured: 12 weeks from treatment administration
End of Treatment Response (Negative HCV RNA at the End of Treatment)
Number with undetectable HCV RNA at end of treatment following 12 weeks of daily Grazoprevir/Elbasvir (100mg/50mg)
Measured: 12 weeks from treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 May 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: Poor recruitment due to new treatments becoming available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Greg Dore, MBBS, Principal investigator, Kirby Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940691
- Sponsor's protocol ID
- VHCRP1510
- Acronym
- DARLO-C
- Status last verified
- Feb 2020
- First submitted
- 19 Oct 2016
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32270056
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02940691
- Acronym / sponsor ID
- DARLO-C / VHCRP1510
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment due to new treatments becoming available.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grazoprevir/elbasvir | Experimental | Drug: Grazoprevir/elbasvirGrazoprevir/elbasvir (100mg/50mg) daily taken orally for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grazoprevir/elbasvirAlso: ZepatierGrazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks. | Drug | Grazoprevir/elbasvir |
Primary outcome
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)
2 secondary outcomes
Number of Participants With Treatment Completion
Time frame: 12 weeks from treatment administration
End of Treatment Response (Negative HCV RNA at the End of Treatment)
Time frame: 12 weeks from treatment administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32270056Grebely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Dore, MBBS principal investigator
Kirby Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grazoprevir/elbasvir in people with Hepatitis C, run by Kirby Institute at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12) (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.