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

Phase 4

Terminated

• Conditions: End Stage Liver Disease; Hepatitis C
• Interventions: Drug: Treatment with Direct Acting Antiviral tablet

• Registration Number: NCT03208127
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2017-11-21
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Results First Submitted: 2022-05-20
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Results First Posted: 2022-07-28
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination	Treatment with Direct Acting Antiviral tablet	12 weeks of HCV treatment with medically appropriate direct acting antiviral

Primary Outcome Measures

Name	Time	Method
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA	12 weeks post treatment	Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values	12 weeks	Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.

Trial Locations

Locations (1)

Masschusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States