NCT03208127

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

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• End Stage Liver Disease
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Treatment with Direct Acting Antiviral tablet	HCV Treatment for 12 Weeks

Timeline

• Start date: 2017-11-21
• Primary completion: 2021-06-04
• Completion: 2021-06-04
• First posted: 2017-07-05
• Last updated: 2022-07-28
• Results posted: 2022-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study