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Eliminating HCV Infection Among PWUD

V

Vancouver Infectious Diseases Centre

Status

Enrolling

Conditions

Hepatitis C, Chronic
Drug Use

Treatments

Drug: Epclusa

Study type

Observational

Funder types

Other

Identifiers

NCT05474781
IN-CA-987-5437

Details and patient eligibility

About

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

Enrollment

300 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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