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Rapid Screening for Hepatitis C & B
Phase 4
Recruiting
Research Sponsored by Jordan Feld
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients with confirmed, active COVID-19 infections
Patients who are unable or decline to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to study the effectiveness of rapid screening methods in diagnosing viral hepatitis infections compared to traditional methods. The goal is to provide same-day results to improve diagnosis rates and help healthcare providers engage with
Who is the study for?
This trial is for adults aged 18 or older who are admitted to General Internal Medicine Inpatient Units at Toronto General Hospital (TGH) or Toronto Western Hospital (TWH). It's designed to test a new rapid screening method for Hepatitis A, B, and C in patients during their hospital stay.
What is being tested?
The study is testing the effectiveness of a quality improvement intervention that involves rapid screening methods for viral hepatitis. This approach aims to provide same-day results, potentially improving diagnosis rates and immediate care engagement compared to traditional weeks-long serum testing processes.
What are the potential side effects?
Since this trial focuses on a non-invasive screening process rather than medication or treatment interventions, there are no direct side effects associated with the procedures being tested.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have an active COVID-19 infection.
Select...
I cannot or do not want to give permission for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.
Number of HCV RNA positive participants who attend their first hepatology appointment.
Number of HCV antibody positive participants who complete an HCV RNA PCR.
Secondary study objectives
Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units.
Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units.
Hepatitis C
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Rapid Point-of-Care TestingExperimental Treatment1 Intervention
Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test (OraSure) and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA (Cepheid) point-of-care testing and confirmed using a standard commercial assay.
Group II: Conventional Serum TestingActive Control1 Intervention
Participants will be screened by conventional HCV antibody (anti-HCV) serology and if screen positive, a second sample will be collected and tested for HCV RNA using a standard commercial assay.
Find a Location
Who is running the clinical trial?
Jordan FeldLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Hepatitis C
40 Patients Enrolled for Hepatitis C