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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02940691




Registration number
NCT02940691
Ethics application status
Date submitted
19/10/2016
Date registered
21/10/2016

Titles & IDs
Public title
Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
Scientific 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
Secondary ID [1] 0 0
VHCRP1510
Universal Trial Number (UTN)
Trial acronym
DARLO-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Grazoprevir/elbasvir

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


Treatment: Drugs: Grazoprevir/elbasvir
Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)
Timepoint [1] 0 0
12 weeks post treatment
Secondary outcome [1] 0 0
Number of Participants With Treatment Completion
Timepoint [1] 0 0
12 weeks from treatment administration
Secondary outcome [2] 0 0
End of Treatment Response (Negative HCV RNA at the End of Treatment)
Timepoint [2] 0 0
12 weeks from treatment administration

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Kirketon Road Centre - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
The Langton Centre - Darlinghurst
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
Drug and Alcohol Clinical Services (Hunter) - Newcastle
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2751 - Kingswood
Recruitment postcode(s) [3] 0 0
2300 - Newcastle

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Greg Dore, MBBS
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02940691