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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 24 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Therapeutic procedure
Therapeutic procedure
Therapeutic procedure
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
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,195 Total Patients Enrolled
110 Trials studying Hepatitis C
32,629 Patients Enrolled for Hepatitis C
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,095 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this clinical experiment?
"Eligibility for this trial is limited to those between 18 and 70 years of age, who are afflicted by hepatitis c. Presently, there is a need to recruit 200 patients in total."
Answered by AI
Are there still openings for participants in this investigation?
"Clinicaltrials.gov provides evidence that this medical trial is not presently enrolling participants, as the most recent update was on October 17th 2022. However, there are still 280 other clinical trials recruiting patients right now."
Answered by AI
Does this research endeavor include individuals aged 45 and over?
"This medical study is open to enrolment from individuals aged 18 and above, up until the age of 70."
Answered by AI
Has the FDA sanctioned Point of Care HCV Viremia (RNA) testing?
"POC HCV Viremia (RNA) testing received a rating of 3 due to the successful completion of Phase 4 trials, signifying that this intervention is already accepted by medical professionals."
Answered by AI
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