Clinical trial NCT04057001: Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study
Official title: Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study (HERCULES)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Transplant; Complications
Hepatitis C
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients active on the waiting list for liver transplantation who are HCV NAT-

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to Transplant
timeFrame: 5 years
Secondary outcomes:
measure: Wait list Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: AnnMarie Liapakis, MD
role: PRINCIPAL_INVESTIGATOR
References: