Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
Megadott ok: The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.
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A vizsgálat adatai
- Ki végzi
- Kirby Institute
- Azonosító
- NCT03981211
- A regiszteradat frissítve
- 2026. május 26.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
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.
Bevonási feltételek: Participants must meet all of the following inclusion criteria to be eligible to participate in this study; 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; Participants must meet the following additional inclusion criteria to be treated in this study; 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.
Kizáró feltételek: Use of prohibited concomitant medications; 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; History of any of the following:; 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; Decompensated liver disease; Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only); Participants who meet any of the exclusion criteria are not to be enrolled in this study; Inability or unwillingness to provide informed consent or abide by the requirements of the study; Actively intoxicated; Participants that meet any of the additional exclusion criteria are not to be treated in this study; Pregnant or nursing female; Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).