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Direct-acting Antivirals

HCV Prophylaxis Strategies for Kidney Transplant Recipients (PREVENT-HCV Trial)

Q: Is this research endeavor still open for participants?

According to the clinicaltrials.gov database, recruitment into this trial has closed; it was initially posted on March 1st 2023 and its last update occurred December 6th 2022. Nonetheless, there are 10 other medical studies presently welcoming new participants.

Q: How widespread is the implementation of this research endeavor in America?

This study is currently enrolling participants from 6 different sites. Memphis, Baltimore and Salt Lake City are a small sample of the available locations; it would be prudent to select the closest one in order to minimize travel expenditures if you choose to join.

Q: What primary goals are investigators hoping to attain through this research?

This clinical trial, which will be assessed 28 days after transplantation, has the primary goal of evaluating a composite event comprised of HCV-related death or treatment-related demise; fibrosing cholestatic hepatitis; and relapse. Secondary objectives consist of assessing graft function (eGFR slope) based on serum creatinine levels; quantifying cumulative incidence and severity of bacterial, fungal, viral and other opportunistic infections; as well as measuring plasma RNA values according to local testing protocols.

N/A

Recruiting

Led By Christine Durand, MD

Research Sponsored by Johns Hopkins 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 during the first year post-transplant

Awards & highlights

PREVENT-HCV Trial Summary

This trial will compare the effectiveness of two approaches to treating HCV in kidney transplant recipients.

Who is the study for?

This trial is for adults over 18 who need a kidney transplant and can give informed consent. They must meet standard criteria for transplantation, have normal liver function (AST or ALT within safe limits), and not be infected with HIV, active hepatitis B, or have had hepatitis C. Pregnant or breastfeeding individuals are excluded.Check my eligibility

What is being tested?

The study compares two timings to start Hepatitis C medication in patients receiving kidneys from HCV-positive donors: 'Prophylaxis' starts treatment before the transplant with a shorter course of medication; 'Transmit and Treat' begins after the transplant with a full course.See study design

What are the potential side effects?

Potential side effects of the Hepatitis C medications used in this trial may include headache, fatigue, nausea, difficulty sleeping, low blood count (anemia), elevated liver enzymes indicating liver injury, rash, itching skin (pruritus), and gastrointestinal discomfort.

PREVENT-HCV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the first year post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the first year post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the first year post-transplant for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite event of HCV-related or HCV treatment-related death, fibrosing cholestatic hepatitis, or HCV relapse

Number of participants with liver injury

Secondary outcome measures

Development of HCV resistance-associated variants (RAVs)

Graft function - eGFR <60

Graft function - eGFR slope

+8 more

PREVENT-HCV Trial Design

2Treatment groups

Experimental Treatment

Group I: Transmit and Treat (T&T)Experimental Treatment1 Intervention

T&T is study-supplied SOF/VEL for 12 weeks starting on post-HCV D+/R- kidney transplant day participant's insurance approves standard of care DAAs, or post-KT day 14, whichever comes first.

Group II: Prophylaxis (P2W)Experimental Treatment1 Intervention

Prophylaxis is one dose of sofosbuvir/velpatasvir (SOF/VEL) pre-HCV D+/R- kidney transplant (KT), continued for 2 weeks.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,377 Total Patients Enrolled

19 Trials studying Hepatitis C

154,857 Patients Enrolled for Hepatitis C

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,270 Previous Clinical Trials

5,485,117 Total Patients Enrolled

53 Trials studying Hepatitis C

9,335 Patients Enrolled for Hepatitis C

Christine Durand, MDPrincipal InvestigatorJohns Hopkins University

7 Previous Clinical Trials

676 Total Patients Enrolled

1 Trials studying Hepatitis C

11 Patients Enrolled for Hepatitis C

Media Library

Prophylaxis (P2W) (Direct-acting Antivirals) Clinical Trial Eligibility Overview. Trial Name: NCT05653232 — N/A

Hepatitis C Research Study Groups: Transmit and Treat (T&T), Prophylaxis (P2W)

Hepatitis C Clinical Trial 2023: Prophylaxis (P2W) Highlights & Side Effects. Trial Name: NCT05653232 — N/A

Prophylaxis (P2W) (Direct-acting Antivirals) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653232 — N/A

Frequently Asked Questions

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

Is this research endeavor still open for participants?

"According to the clinicaltrials.gov database, recruitment into this trial has closed; it was initially posted on March 1st 2023 and its last update occurred December 6th 2022. Nonetheless, there are 10 other medical studies presently welcoming new participants."

Answered by AI

How widespread is the implementation of this research endeavor in America?

"This study is currently enrolling participants from 6 different sites. Memphis, Baltimore and Salt Lake City are a small sample of the available locations; it would be prudent to select the closest one in order to minimize travel expenditures if you choose to join."

Answered by AI

What primary goals are investigators hoping to attain through this research?

"This clinical trial, which will be assessed 28 days after transplantation, has the primary goal of evaluating a composite event comprised of HCV-related death or treatment-related demise; fibrosing cholestatic hepatitis; and relapse. Secondary objectives consist of assessing graft function (eGFR slope) based on serum creatinine levels; quantifying cumulative incidence and severity of bacterial, fungal, viral and other opportunistic infections; as well as measuring plasma RNA values according to local testing protocols."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

2023. "Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05653232.

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