Epclusa for Heart Transplant Recipients with Hepatitis C
(TROJAN-C Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the drug Epclusa (sofosbuvir/velpatasvir) to determine its safety and effectiveness for heart transplant patients receiving hearts from hepatitis C (HCV) positive donors. The researchers aim to discover if this treatment can enable HCV-negative patients to safely receive hearts from HCV-positive donors. Suitable candidates for this trial are those awaiting a heart transplant without an active HCV infection. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Epclusa is likely to be safe for humans?
Research has shown that Epclusa, a combination of sofosbuvir and velpatasvir, has been tested in individuals who received heart transplants from donors with hepatitis C. These studies found Epclusa to be both effective and safe. For example, in a study on kidney transplants, patients treated with the drug experienced positive outcomes without major safety issues. Although detailed information for heart transplants is limited, safety results in similar transplant cases have been comparable.
The FDA has already approved Epclusa for treating hepatitis C in other contexts, providing some reassurance about its safety. This trial aims to gather more detailed safety information, offering an opportunity to assess how well the treatment is tolerated in heart transplant recipients.12345Why do researchers think this study treatment might be promising?
Epclusa is unique because it provides a simplified treatment option for heart transplant recipients with Hepatitis C. Unlike other treatments that may require multiple drugs or longer durations, Epclusa combines two active ingredients, sofosbuvir and velpatasvir, into a single pill. This combination targets the virus more effectively across all genotypes of Hepatitis C. Researchers are excited because its straightforward regimen could make managing Hepatitis C post-transplant easier and potentially more successful.
What evidence suggests that Epclusa might be an effective treatment for heart transplant recipients with Hepatitis C?
Research has shown that Epclusa, the treatment under study in this trial, effectively treats hepatitis C in heart transplant recipients. Studies found that the hepatitis C virus (HCV) in patients disappeared within about two weeks and remained undetectable afterward. Almost all patients had their new hearts survive at least a year, with similar survival rates regardless of whether the heart came from a donor with or without HCV. This indicates that Epclusa helps the body accept a new heart while also clearing the hepatitis C virus. The results suggest that using hearts from HCV-positive donors can be safe and effective when combined with this treatment.14678
Who Is on the Research Team?
Shelley A Hall, MD, FACC, FHFSA
Principal Investigator
Baylor University Medical Center/ Baylor Scott & White Research Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 who need a heart transplant and don't have Hepatitis C. They must be willing to give consent, not have had any organ transplants before, and can't be pregnant or have severe kidney disease requiring dialysis. People with a history of HIV or certain levels of liver damage aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Transplantation and Immediate Post-Transplant Monitoring
Participants receive heart transplants from HCV-positive donors and are closely monitored with serial HCV PCR as inpatients during the immediate post-OHT hospitalization.
Treatment
Epclusa® therapy is administered for a 12-week course if recipients develop confirmed viremia by HCV PCR.
Follow-up
Participants are monitored for sustained virologic response 12 weeks after discontinuation of therapy and for 1-year post-transplant survival.
What Are the Treatments Tested in This Trial?
Interventions
- Epclusa
Trial Overview
The study tests the safety and effectiveness of using hearts from donors with Hepatitis C in recipients without the virus, treating them with Epclusa after transplantation to prevent infection.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Epclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient.
Epclusa is already approved in European Union, United States for the following indications:
- Chronic hepatitis C
- Chronic hepatitis C
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor
Citations
Epclusa® Use Post-Heart Transplant
Nearly all participants (94%; 15/16) with ≥12 months of follow-up had graft survival, and. 1 recipient of a heart transplant died at post-transplant Month 8 ( ...
Review of heart transplantation from hepatitis C-positive ...
With the effective treatment against HCV with DAAs, the 1-year survival rate is 90.4% in HCV-positive recipients similar to HCV-negative recipients[37,48,61].
Heart and Lung Transplants from HCV-Infected Donors to ...
The hepatitis C viremia was cleared in all recipients by approximately 2 weeks, and HCV remained undetectable thereafter. This regimen was ...
Transplant of Redeemed Organs by Judicious ...
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative ...
8 versus 12 Week Complete Viral Suppression After ...
Current research demonstrates acceptable rates of survival in patients receiving heart transplants from hepatitis c positive donors.
Hepatitis C Positive Organ Donation in Heart Transplantation
In another study, 261 HT recipients of HCV + donors demonstrated 50% lower survival at 1, 5, and 10 years compared to recipients of HCV − donor ...
Sofosbuvir/Velpatasvir Prophylaxis for 12 Weeks in ...
Conclusions. Sofosbuvir/Velpatasvir pre- and post-transplantation treatment was effective and safe in HCV-uninfected recipients who received a transplant kidney ...
8.
hcvguidelines.org
hcvguidelines.org/guidance/treatment-of-hcv-uninfected-transplant-recipients-receiving-organs-from-hcv-viremic-donors/Treatment of HCV-Uninfected Transplant Recipients ...
Although no published data are available regarding the long-term (beyond 1 to 2 years) consequences to HCV-negative recipients transplanted with ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.