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Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

NCT03981211 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-06

No results posted yet for this study

Summary

This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.

Conditions

  • Hepatitis C
  • Liver Inflammation
  • Liver Cirrhoses

Interventions

DRUG

Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet

8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily

DRUG

Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet

4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily

Sponsors & Collaborators

  • Kirby Institute

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2025-02-12
Completion
2025-02-12

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981211 on ClinicalTrials.gov