DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant

Mass General Brigham

Status and phase: Terminated; Phase 4

Conditions: Hepatitis C; End Stage Liver Disease

Treatments: Drug: Treatment with Direct Acting Antiviral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03208127

2017P000653

Details and patient eligibility

About

This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Full description

Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient is Age ≥ 18 years
• Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
• HCV naïve
• Able to sign informed consent

Exclusion criteria

• Pregnant or nursing (lactating) women
• Human immunodeficiency virus (HIV) positivity
• Need for dual organ transplant
• Any contra-indication to liver transplantation per center protocol

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination

Experimental group

Description:

12 weeks of HCV treatment with medically appropriate direct acting antiviral

Treatment:

Drug: Treatment with Direct Acting Antiviral tablet