Recruiting

HCV Infection

Sponsor:

Vancouver Infectious Diseases Centre

Code:

NCT05474781

Conditions

Hepatitis C, Chronic

Drug Use

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Epclusa

Study Details

Brief summary:

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

Study ID

NCT05474781

Start date

Feb 22, 2019

Status verified date

Jul, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Epclusa

HCV treatment

Primary outcome measure

  • The proportion of individuals enrolled in the study who initiate HCV treatment [ Time Frame: 60 months ]

Central Contacts and Locations

Locations

Vancouver Infectious Diseases Centre

Recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

Contacts

Principal Investigator:

Brian Conway, MD

More Information

Sponsor

Vancouver Infectious Diseases Centre

Last update posted

Jul 26, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Infectious Diseases Centre on 2022-07-26.