Status:
UNKNOWN
Pharmacist-led Hepatitis C Management
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from rece...
Eligibility Criteria
Inclusion
- HCV infection
- HCV RNA \> 1,000 IU/mL
- Aged 18 to 80
- Willingness and capacity to provide informed consent
Exclusion
- Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
- Platelets \< 75,000/mm3, total albumin \<35 g/L, total bilirubin (total and direct) \>34.2 μmol/L, International Normalized Ratio (INR) \>1.5
- History of current or past hepatocellular carcinoma
- Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
- Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
- Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
- Significant co-morbid illness that precludes inclusion in the opinion of the investigator
- Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
- Pregnancy/breast-feeding/inability to use contraception
- Use of concomitant contraindicated drugs
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04322981
Start Date
April 13 2022
End Date
December 1 2023
Last Update
April 27 2022
Active Locations (1)
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1
Specialty Rx Solutions
Toronto, Ontario, Canada, M4Y 1G7