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Hepatitis C Positive Liver Transplants for Liver Transplant Recipients
Phase 2
Waitlist Available
Led By Naudia Jonassaint, MD
Research Sponsored by Naudia Jonassaint. MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with end-stage liver disease listed for liver transplantation at UPMC.
Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of transplanting livers from donors who are either positive or negative for the Hepatitis C virus. Treatment and prophylaxis will be administered to the recipients based on the donor's status.
Who is the study for?
This trial is for adults over 18 on the UPMC liver transplant waitlist, without HIV or hepatitis B, and no history of multi-organ transplants or certain drug uses. They must be willing to travel for post-transplant care and use contraception for a year.Check my eligibility
What is being tested?
The study tests if Hepatitis C positive livers can safely be transplanted into patients without Hepatitis C. It involves two approaches: one where treatment starts only if the virus is detected after transplant, and another with immediate preventive treatment.See study design
What are the potential side effects?
Potential side effects from sofosbuvir/velpatasvir include headache, fatigue, nausea, insomnia, and sometimes more serious reactions like slowed heart rate or liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on the liver transplant list at UPMC for end-stage liver disease.
Select...
I can travel to UPMC for follow-up visits for at least a year after my transplant.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
HCV free at 1 year
Secondary outcome measures
All-cause mortality
Incidence of allograft rejection
Incidence of graft loss
+2 moreSide effects data
From 2019 Phase 4 trial • 11 Patients • NCT0323515418%
GI distress
9%
Scabies
9%
Altered Mental Status
9%
Seizure
9%
Visual Hallucination
9%
Suicidal Ideation
9%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm Intervention
Trial Design
2Treatment groups
Experimental Treatment
Group I: HCV seropositive viremic (HCV Ab+/NAT+) donorExperimental Treatment1 Intervention
Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
Group II: HCV seropositive non-viremic (HCV Ab+/NAT-) donorExperimental Treatment1 Intervention
Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.
Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Velpatasvir
FDA approved
Find a Location
Who is running the clinical trial?
Naudia Jonassaint. MDLead Sponsor
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,177 Total Patients Enrolled
2 Trials studying Hepatitis C
452 Patients Enrolled for Hepatitis C
Naudia JonassaintLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for hepatitis C.You are on the waiting list for a transplant involving multiple organs.You have a medical or mental condition that could make it risky to participate in the study or could affect your ability to take part in it.You engage in risky behavior that increases your chances of getting Hepatitis C, such as injecting drugs or using illicit drugs through the nose.I am on the liver transplant list at UPMC for end-stage liver disease.I am allergic to sofosbuvir/velpatasvir.I can travel to UPMC for follow-up visits for at least a year after my transplant.You are pregnant.You do not have a living donor who can donate a liver for your transplant.I have used amiodarone for atrial fibrillation in the last year.I am 18 years old or older.I have received an organ transplant.
Research Study Groups:
This trial has the following groups:- Group 1: HCV seropositive viremic (HCV Ab+/NAT+) donor
- Group 2: HCV seropositive non-viremic (HCV Ab+/NAT-) donor
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What goals is this research endeavor attempting to realize?
"This trial, which will run for a period of 5 years, intends to evaluate the HCV free rate after 1 year. Secondary objectives include quantifying graft loss at 5 years post-enrollment, measuring waitlist time following enrollment and calculating all-cause mortality over the same duration."
Answered by AI
How many individuals are being inducted into this research endeavor?
"Unfortunately, this trial is no longer open for recruitment. Initially posted on August 15th 2019 and last updated October 6th 2022. If you're searching other trials, there are 330 studies related to hepatitis c presently enrolling patients as well as 27 sofosbuvir/velpatasvir trials that are still seeking participants."
Answered by AI
Is this trial actively seeking participants?
"Regrettably, this clinical trial is no longer accepting participants. Originally posted on August 15th 2019 and last modified on October 6th 2022, it has since been superseded by 330 studies recruiting individuals with hepatitis c and 27 trials for sofosbuvir/velpatasvir that remain open to new patients."
Answered by AI
What deleterious effects could be associated with taking sofosbuvir/velpatasvir?
"Although the safety of sofosbuvir/velpatasvir has been clinically demonstrated, there is no efficacy data available. This results in a score of 2 on our team's 1-3 scale."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
UPMC
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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