Heart Failure study: Epclusa
Official title Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
ClinicalTrials.gov ID: NCT03383419
What this study is testing
What is Epclusa?
An investigational oral medication being studied for use after heart transplant from an HCV-positive donor. is designed to inhibit hepatitis C virus replication by combining a nucleotide analog with a protease inhibitor.
Also referred to as sofosbuvir/velpatasvir.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether using hearts from hepatitis‑C donors is safe. It also looks at how well the heart works when you take a specific antiviral medication.
- Who it's for
- You may be able to join if you need a heart transplant and do not have hepatitis‑C.
- What's involved
- You will receive a heart from a donor who had hepatitis‑C. You will take the antiviral drug sofosbuvir and velpatasvir for a period after the transplant. You will have blood tests to see how well the heart works and if the drug is safe.
- Time commitment
- The study lasts about a year, with visits at the hospital after the transplant and during follow‑up appointments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Willing and capable of providing written informed consent
- Age ≥ 18 years
- Listed for isolated orthotopic heart transplant
- HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or...
You likely can't join if
- Listed for combined organ transplant
- History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
- Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant...
- Cirrhosis, as indicated by liver biopsy,
- Portal hypertension as indicated by a hepatic venous pressure gradient \> 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST \> 3x ULN...
- History of prior solid organ transplant
See the full eligibility criteria
- Willing and capable of providing written informed consent
- Age ≥ 18 years
- Listed for isolated orthotopic heart transplant
- HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection
- Listed for combined organ transplant
- History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
- Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,
- Cirrhosis, as indicated by liver biopsy,
- Portal hypertension as indicated by a hepatic venous pressure gradient \> 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST \> 3x ULN unless adjudicated to be from a non-hepatic cardiac or skeletal...
- History of prior solid organ transplant
- Pregnant individuals
- History of HIV infection
- History of severe renal disease currently requiring dialysis. Chronic kidney disease with creatinine clearance \<30 ml/min/1.73m2 (by MDRD method) at screening or on last two consecutive measurements before acceptance...
- Patients who have undergone or who will undergo immune desensitization therapy
- Prospective-positive cross-match or predicted positive cross-match
- Patients unwilling to notify their sexual partner(s) of participation in this trial
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.