CClinicalTrials.gg
Status unknownNCT05474781Updated Jul 26, 2022

Eliminating HCV Infection Among PWUD

An observational study in Hepatitis C, Chronic and Drug Use, sponsored by Vancouver Infectious Diseases Centre. Status unknown at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Vancouver Infectious Diseases Centre · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
19 Years and older
Sex
All
01

Study summary

Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment

02

Conditions studied

  • Hepatitis C, Chronic
  • Drug Use
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 300 is above the median of 244 across 567 observational studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Vancouver Infectious Diseases Centre is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HCV-infected current drug users

Inclusion criteria

  1. Ability to review, sign and date the IRB/IEC approved informed consent form
  2. Age ≥19 years
  3. Documented HCV RNA positive for 6 months or more, with any HCV genotype
  4. Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

Exclusion criteria

Exclusion Criteria:

  1. Previous DAA-based HCV treatment
  2. Pregnant or breast-feeding
  3. Indications of decompensated liver disease
  4. Diagnosis of active hepatocellular carcinoma
  5. Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
  6. Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
  7. Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DrugEpclusa

    HCV treatment

06

What researchers measure

Primary outcomes

  1. The proportion of individuals enrolled in the study who initiate HCV treatment

    Time frame: 60 months

Secondary outcomes

  1. The proportion of individuals enrolled in the study who achieve sustained virologic response

    Time frame: 72 months

07

Study locations

1 of 1 sites recruiting
  • Vancouver Infectious Diseases Centre
    Vancouver, British Columbia V6Z 2C7, Canada
    • Rossitta Yung · Contact · rossitta.yung@vidc.ca · 604-642-6429
    • Brian Conway, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05474781
Lead sponsor
Vancouver Infectious Diseases Centre
Responsible party
Sponsor
First posted
Jul 26, 2022
Start date
Feb 22, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 26, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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