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Antiviral
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
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
2015
N/A
~450
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,379 Total Patients Enrolled
110 Trials studying Hepatitis C
32,632 Patients Enrolled for Hepatitis C
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,586 Total Patients Enrolled
15 Trials studying Hepatitis C
7,305 Patients Enrolled for Hepatitis C
Robert S Brown, MD, MPHPrincipal InvestigatorWeill Medical College of Cornell University
3 Previous Clinical Trials
463 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of liver cancer.I am between 18 and 70 years old, or an emancipated minor aged 16 or over.I have never been treated for Hepatitis C.I have a history of active Hepatitis B or a positive HBsAg test.I have never had severe liver problems like encephalopathy, bleeding varices, or ascites.
Research Study Groups:
This trial has the following groups:- Group 1: HCV Education
- Group 2: Point of Care (POC) HCV Viremia (RNA) testing
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.