Education + Antiviral Therapy for Hepatitis C

Phase 4

Recruiting

Led By Robert S Brown, MD, MPH

Research Sponsored by Weill Medical College of Cornell University

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 up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if giving people more info on HCV via video increases their chances of starting & completing treatment.

Who is the study for?

This trial is for men and women aged 18 to 70 who have never been treated for Hepatitis C. They must be HCV antibody positive but cannot have had liver cancer, active Hepatitis B, undetectable HCV RNA, or severe liver disease like encephalopathy or ascites.

What is being tested?

The study tests if a model combining a point-of-care HCV RNA test with video-based patient education improves the start and completion rates of Hepatitis C treatment using Glecaprevir and Pibrentasvir medications.

What are the potential side effects?

Possible side effects from Glecaprevir and Pibrentasvir may include headache, fatigue, nausea, diarrhea. Side effects vary by individual and should be discussed with a healthcare provider.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Point of Care (POC) HCV Viremia (RNA) testingExperimental Treatment3 Interventions

All participants will have standardized laboratory assessments for HCV Viremia (RNA testing) as well as Cepheid POC HCV Viremia (RNA) test. The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.

Group II: HCV EducationActive Control2 Interventions

The intervention of HCV education will be performed at the addiction care setting for video- based patient education. Health care provide delivered patient education is the standard of care referral approach. HCV Education will include HCV disease overview, HCV screening, taking Glecaprevir/Pibrentasivir (G/P), and post study drug assessment and management. Participants may be randomized to either the video-based patient education or the HCV delivered patient education.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glecaprevir and Pibrentasvir

2021

Completed Phase 4

~450

Do I qualify?Apply below to find out