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

NCT04057001 | Terminated

• 1 other identifier: 2000022932
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wait list Mortality

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Unwilling to consent to post transplant DAA therapy
• Hepatitis B Virus (HBV) viremia
• HCV NAT+
• Deceased Donor organs
• HBV cAb donors will be considered on a case by case basis based on specific recipient factors and plan for post-transplant prophylaxis
• Bilirubin \>3
• Positive nucleotide testing for HBV
• Radiographic, laboratory or other clinical evidence of portal hypertension
• Fibrosis on pre-procurement liver biopsy fibrosis \> F1 or fibroscan \>7 (if both are done and discordant, use biopsy to determine eligibility

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

RNA characterization of the tissue samples only. No plans for cell lines/ exome or genome sequencing

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• AnnMarie Liapakis, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: August 14, 2019
• Study Start: July 1, 2019
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

US (1)