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Rapid Point-of-Care Testing for Hepatitis C

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants enrolled in this clinical trial?

"Indeed, details on clinicaltrials.gov indicate that this research endeavor is currently seeking suitable candidates. Clinical trial information was initially made public on February 1st, 2024 and last revised on February 6th, 2024. The study aims to enroll a total of 2920 participants across two designated locations."

Answered by AI

Has the Rapid Point-of-Care Testing been granted approval by the FDA?

"Based on our evaluation at Power, the safety rating for Rapid Point-of-Care Testing is 3. This score reflects that the treatment has passed regulatory approval as indicated by being in Phase 4 of clinical trials."

Answered by AI

Are individuals currently being enrolled in this ongoing medical study?

"Indeed, the details on clinicaltrials.gov indicate an ongoing recruitment phase for this trial. The initial posting date was 2nd January 2024 with the most recent update on 6th February 2024. A total of 2920 participants are being sought after across two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

UHN Inpatient Hepatitis C & B Screening

Jordan Feld 2024. "UHN Inpatient Hepatitis C & B Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04620226.

All > Autoimmune Hepatitis > Hepatitis B