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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:

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I currently have an active COVID-19 infection.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

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 more

Awards & 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.

0 / 2Eligibility criteria met