Eliminating HCV Infection Among PWUD

NCT ID: NCT05474781

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-22

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hepatitis C, Chronic Drug Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Epclusa

HCV treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver Infectious Diseases Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vancouver Infectious Diseases Centre

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Rossitta Yung

Role: primary

604-642-6429 ext. 303

Other Identifiers

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IN-CA-987-5437

Identifier Type: -

Identifier Source: org_study_id

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