Hepatitis C, ChronicNCT05474781
Eliminating HCV Infection Among PWUD
An observational study of Hepatitis C, Chronic and Drug Use, run by Vancouver Infectious Diseases Centre at 1 site in Canada.
Trial summary
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Drug Use
- What is being tested?
- Epclusa
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCV-infected current drug users
Who may be able to join
- Ability to review, sign and date the IRB/IEC approved informed consent form
- Age ≥19 years
- Documented HCV RNA positive for 6 months or more, with any HCV genotype
- Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program
Who cannot join
- Previous DAA-based HCV treatment
- Pregnant or breast-feeding
- Indications of decompensated liver disease
- Diagnosis of active hepatocellular carcinoma
- Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
- Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
- Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, V6Z 2C7
Rossitta Yung, 604-642-6429 ext. 303, rossitta.yung@vidc.ca
Brian Conway, MD
About this study
Official title: Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment
- Conditions
- Hepatitis C, Chronic, Drug Use
- Being tested
- Epclusa
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpclusaDrug
HCV treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of individuals enrolled in the study who initiate HCV treatment
Measured: 60 months
Secondary outcomes (1)
The proportion of individuals enrolled in the study who achieve sustained virologic response
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start22 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Infectious Diseases Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474781
- Sponsor's protocol ID
- IN-CA-987-5437
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach
- ClinicalTrials.gov ID
- NCT05474781
- Acronym / sponsor ID
- IN-CA-987-5437
- Conditions
- Hepatitis C, Chronic, Drug Use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vancouver Infectious Diseases CentreUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV-infected current drug users
Key inclusion criteria (4 listed)
- Ability to review, sign and date the IRB/IEC approved informed consent form
- Age ≥19 years
- Documented HCV RNA positive for 6 months or more, with any HCV genotype
- Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program
Key exclusion criteria (7 listed)
- Previous DAA-based HCV treatment
- Pregnant or breast-feeding
- Indications of decompensated liver disease
- Diagnosis of active hepatocellular carcinoma
- Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
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 |
|---|---|---|
| EpclusaHCV treatment | Drug | – |
Primary outcome
The proportion of individuals enrolled in the study who initiate HCV treatment
Time frame: 60 months
1 secondary outcome
The proportion of individuals enrolled in the study who achieve sustained virologic response
Time frame: 72 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Drug Use, run by Vancouver Infectious Diseases Centre at 1 site in Canada.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of individuals enrolled in the study who initiate HCV treatment (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.