Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study

Hepatitis C Clinical Trial

— HERCULES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04057001
• Other study ID #: 2000022932
• Status: Terminated
• Start date: July 1, 2019
• Est. completion date: March 6, 2023

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Liver Transplant; Complications

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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