Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing … (NCT03981211) | Clinical Trial Compass
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Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
Australia60 participantsStarted 2021-02-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have voluntarily signed the informed consent form.
✓. 18 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:
Exclusion criteria
✕. Inability or unwillingness to provide informed consent or abide by the requirements of the study
✕. Actively intoxicated.
✕. History of any of the following:
✕. Creatinine clearance (CLcr) \< 30 mL/min at screening (Cohort B only)
✕. Pregnant or nursing female
✕. Decompensated liver disease
✕. Use of prohibited concomitant medications
What they're measuring
1
SVR12 outcomes for all total patient population
Timeframe: 12 weeks post completion of commenced treatment