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NCT05474781 Clinical Trial

Eliminating HCV Infection Among PWUD

Hepatitis C, Chronic Clinical Trial

Official title:
Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05474781
Other study ID # IN-CA-987-5437
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 22, 2019
Est. completion date December 31, 2024

Study information
Verified date July 2022
Source Vancouver Infectious Diseases Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Epclusa
HCV treatment

Locations
Country Name City State
Canada Vancouver Infectious Diseases Centre Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
Vancouver Infectious Diseases Centre

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of individuals enrolled in the study who initiate HCV treatment 60 months
Secondary The proportion of individuals enrolled in the study who achieve sustained virologic response 72 months
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