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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Drug Use
• Hepatitis C
• Hepatitis C, Chronic

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