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Direct-acting Antiviral

Epclusa (SOF/VEL) for Chronic Hepatitis C (NOW Trial)

Phase 4

Waitlist Available

Led By Meghan D Morris, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

NOW Trial Summary

This trial is testing a new way to give people with chronic hepatitis C virus (HCV) infection their medication in order to see if it will increase uptake and reduce loss-to-follow-up.

Eligible Conditions

Chronic Hepatitis C

NOW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

SVR-12

SVR-12, by project site

Secondary outcome measures

Acceptability: Number of persons who decline POD treatment

Acceptability: median age by declined

Acceptability: percent female by declined

+11 more

NOW Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: at Point-of-Diagnosis HCV treatmentExperimental Treatment2 Interventions

At the point of HCV infection diagnosis, (HCV RNA positive and anti-HCV positive) individuals who meet eligibility criteria and elect to start HCV treatment at the same visit and monitored at two-week intervals at the community-site.

Group II: Passive observationActive Control1 Intervention

Participants who test positive for HCV chronic infection (HCV RNA positive, and anti-HCV positive) but elect to not enroll in the intervention arm. Electronic medical record data will be reviewed for up to 2 years for HCV related care information (e.g., HCV treatment start date, end date, SVR-12).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epclusa (SOF/VEL)

2020

Completed Phase 4

~90

Fibroscan® 430 Mini Plus

2020

Completed Phase 4

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,080 Previous Clinical Trials

837,615 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,498 Previous Clinical Trials

11,936,262 Total Patients Enrolled

Meghan D Morris, PhDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

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

What are the chief aims of this trial?

"Per Gilead Sciences, the primary outcome assessed over 24 weeks from the commencement of treatment is SVR-12 at each site. Secondary outcomes examined include Acceptability: percent homeless in past 30 days; Treatment adherence at 12 weeks; and Acceptability: percent injected drugs in past 30 days."

Answered by AI

Has the Fibroscan® 430 Mini Plus attained regulatory endorsement from the FDA?

"Due to the completion of Phase 4 trials for Fibroscan® 430 Mini Plus, it has been granted approval and our team at Power assign a score of 3 in terms of safety."

Answered by AI

Is this investigation open to geriatric participants?

"To meet the parameters of this trial, potential participants must be at least 18 years old and no older than 64."

Answered by AI

Does my profile meet the eligibility criteria for this research study?

"In order to join this clinical trial, potential participants must have a diagnosis of chronic hepatitis c and fall within the 18-64 age range. Currently, 86 individuals are needed for recruitment."

Answered by AI

How many individuals are being recruited for participation in this clinical trial?

"At this stage, no more patients are being accepted into this clinical trial. The experiment was initially put up on July 1st 2020 and underwent its last amendment in June 6th 2022. If you're still searching for other studies to take part in, 97 trials concerning hepatitis c chronicity and 27 Fibroscan® 430 Mini Plus research projects remain open for recruitment."

Answered by AI

Are there any available slots remaining in this scientific experiment?

"According to the clinicaltrials.gov registry, this medical trial is no longer actively recruiting participants; however, there are still 124 other studies that require volunteers at present time. This particular trial was posted on July 1st 2020 and last edited June 6th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

2020. "The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03987503.