Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
TOPIC
1 other identifier
interventional
60
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedStudy Start
First participant enrolled
February 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2025
CompletedMarch 6, 2024
December 1, 2023
4 years
May 31, 2019
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SVR12 outcomes for all total patient population
To 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 and commencing inpatient DAA treatment within public hospital services.
12 weeks post completion of commenced treatment
Study Arms (2)
Cohort A: 8 weeks G/P standard therapy
EXPERIMENTAL8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
Cohort B: 4 weeks SOF/G/P shortened therapy
EXPERIMENTAL4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).
Interventions
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
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Eligibility Criteria
You may qualify if:
- Have voluntarily signed the informed consent form.
- years of age or older.
- Injected drugs within the last 6 months
- Hospitalised with an IRID with an anticipated inpatient stay of \> 1 week
- HCV RNA positive
- Compensated liver disease
- Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
- If co-infection with HIV is documented, the subject must meet the following criteria:
- ART naïve with CD4 T cell count \>500 cells/mm3; OR
- On a stable ART regimen (containing only permissible ART) for \>4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
You may not qualify if:
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Actively intoxicated.
- History of any of the following:
- b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs
- Creatinine clearance (CLcr) \< 30 mL/min at screening (Cohort B only)
- Pregnant or nursing female
- Decompensated liver disease
- Use of prohibited concomitant medications
- Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks)
- Prior treatment failure with an NS5A based DAA regimen
- Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay \> 1 week may also be included at discretion of study team.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Study Sites (7)
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010, Australia
Blacktown Mt Druitt Hospital
Sydney, New South Wales, 2148, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
St Vincent's Hospital
Melbourne, Victoria, 3065, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 10, 2019
Study Start
February 12, 2021
Primary Completion
February 12, 2025
Study Completion
February 12, 2025
Last Updated
March 6, 2024
Record last verified: 2023-12