NCT05474781

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

4.9 years

First QC Date

July 7, 2022

Last Update Submit

July 22, 2022

Conditions

Hepatitis C, ChronicDrug Use

Outcome Measures

Primary Outcomes (1)

  • The proportion of individuals enrolled in the study who initiate HCV treatment

    60 months

Secondary Outcomes (1)

  • The proportion of individuals enrolled in the study who achieve sustained virologic response

    72 months

Interventions

EpclusaDRUG

HCV treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HCV-infected current drug users

You may qualify if:

  • Ability to review, sign and date the IRB/IEC approved informed consent form
  • Age ≥19 years
  • Documented HCV RNA positive for 6 months or more, with any HCV genotype
  • Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

You may not qualify if:

  • Previous DAA-based HCV treatment
  • Pregnant or breast-feeding
  • Indications of decompensated liver disease
  • Diagnosis of active hepatocellular carcinoma
  • Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
  • Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
  • Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Infectious Diseases Centre

Vancouver, British Columbia, V6Z 2C7, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 26, 2022

Study Start

February 22, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)