Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)

Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)

Compare wait list mortality and time to liver, heart or kidney transplant for registrants listed to consider allografts from Hepatitis C Virus (HCV) Nucleic Amplification Testing (NAT)+ donors versus those who are not . The umbrella protocol has been set up to include heart and kidney transplant recipients.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C; Liver Transplant; Complications

Detailed Description

The research project will take place within each transplant center and can be incorporated into routine pre- and post-transplant care (i.e., no extra visits are needed). Enrolling in this study will enable patients to accept offers of HCV NAT+ livers, in addition to the regular waitlist. All other transplant eligibility criteria have to be met per routine care. The multi-site project will establish a biorepository and prospective data collection with the goal of obtaining more generalizable results than single-center studies alone can.

Patients who enroll in the study but receive an HCV- organ instead, will be (data collection only) as part of the study.

Aims are to evaluate sustained virologic response (SVR) rates post-transplant with Direct Acting Anti-Viral (DAA) therapy, as well as long-term patient and graft outcomes.

Evaluate the financial impact of timely transplant and DAA therapy compared to traditional wait time health care expenditure.

Create a blood and tissue biorepository for future evaluation of HCV NAT+ allografts and their outcomes

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients active on the waiting list for liver transplantation who are HCV NAT-

Description

Recipient Inclusion Criteria:

1. Adult patients > or = 18 years of age
2. Actively listed for Liver Transplant (LT) or Simultaneous Liver and Kidney (SLK)
3. Current HCV NAT- status
4. Review by multi-disciplinary transplant team that patient is appropriate for listing for HCV NAT+ liver offers

Recipient Exclusion Criteria:

1. Unwilling to consent to post transplant DAA therapy
2. Hepatitis B Virus (HBV) viremia

Donor Inclusion Criteria:

1. HCV NAT+
2. Deceased Donor organs
3. HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis

Donor Exclusion Criteria:

1. Bilirubin >3
2. Positive nucleotide testing for HBV
3. Radiographic, laboratory or other clinical evidence of portal hypertension
4. Fibrosis on pre-procurement liver biopsy fibrosis > F1 or fibroscan >7 (if both are done and discordant, use biopsy to determine eligibility

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients who received a HCV+ liver transplant; Patients on a wait list for a liver transplant who agree to receiving a hepatitis C+ virus positive tested liver transplant.
Patients who received a HCV- liver transplant; Patients on a wait list for a liver transplant who agree to receiving a hepatitis C- virus positive tested liver transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Transplant	Number of days between date of adding patient to the waitlist and transplant date comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wait list Mortality	Number of days between adding patient to the waitlist to death on the waitlist comparing waitlist registrants listed to accept HCV NAT+ donor organs with those followed per standard of care (not accepting HCV NAT+ donor organs).	5 years

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: AnnMarie Liapakis, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 2000022932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes