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Anti-viral

Epclusa for Hepatitis C (KeY Treat Trial)

Phase 4
Waitlist Available
Led By Jennifer Havens, PhD
Research Sponsored by Jennifer Havens
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
RNA positive for HCV
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits 1-5, 1 to 12 weeks post-baseline
Awards & highlights

KeY Treat Trial Summary

This trial is testing whether making it easier for people with hepatitis C to get treatment will improve their health in Perry County, Kentucky.

Who is the study for?
This trial is for adults over 18 living in Perry County, Kentucky who have tested RNA positive for Hepatitis C. It's not open to those under 18, pregnant women during pregnancy, or anyone unable to give informed consent.Check my eligibility
What is being tested?
The study tests the impact of providing easy access to a hepatitis C treatment called Sofosbuvir/velpatasvir (Epclusa®) without barriers like cost and insurance issues in a rural community affected by opioid use.See study design
What are the potential side effects?
Sofosbuvir/velpatasvir may cause headaches, fatigue, nausea, insomnia and sometimes more serious side effects such as slow heart rate or liver problems. Each person's experience with side effects can vary.

KeY Treat Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tested positive for hepatitis C.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.

KeY Treat Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits 1-5, 1 to 12 weeks post-baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 1-5, 1 to 12 weeks post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Re-infection
Sustained Virologic Response (SVR)
Treatment Completion
+1 more
Secondary outcome measures
Incidence of HCV
Prevalence of HCV

KeY Treat Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HCV Positive Study ParticipantsExperimental Treatment1 Intervention
Study participants will be administered a standard 12-week course of sofosbuvir/velpatasvir (Epclusa®).
Group II: Control (Pike County)Active Control1 Intervention
After completion of the study, we will compare HCV incidence and prevalence rates in Perry County (intervention) and Pike County (control). This will be measured through data provided by the local health departments of each county. Confidential Hepatitis C screening will be conducted in some cases, and resources will be provided to those testing positive but they will not receive treatment as part of this study.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiOTHER
852 Previous Clinical Trials
535,558 Total Patients Enrolled
19 Trials studying Hepatitis C
36,912 Patients Enrolled for Hepatitis C
University of KentuckyOTHER
182 Previous Clinical Trials
225,838 Total Patients Enrolled
1 Trials studying Hepatitis C
234 Patients Enrolled for Hepatitis C
University of BristolOTHER
103 Previous Clinical Trials
25,015,632 Total Patients Enrolled
3 Trials studying Hepatitis C
28,358 Patients Enrolled for Hepatitis C

Media Library

Hepatitis C Research Study Groups: HCV Positive Study Participants, Control (Pike County)

Frequently Asked Questions

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

How many participants have been recruited to take part in this trial?

"Affirmative. According to clinicaltrials.gov, this medical study which was originally posted on September 23rd 2019 is actively enrolling participants. Approximately 900 individuals need to be recruited from one site for the trial's success."

Answered by AI

Are individuals currently being recruited to take part in this trial?

"According to clinicaltrials.gov, this study is currently in the process of recruiting participants who meet its criteria; it was initially published on September 23rd 2019 and most recently updated on September 25th 2022."

Answered by AI

Could you please elucidate the potential perils of using Sofosbuvir/velpatasvir (Epclusa®)?

"Data from the Phase 4 clinical trial supports that Sofosbuvir/velpatasvir (Epclusa®) is safe, and thus our team at Power gave it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Nevada
How old are they?
18 - 65
What site did they apply to?
ARH Medical Mall
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~32 spots leftby Aug 2024