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

Phase 4

Terminated

• Conditions: End Stage Heart Disease; Hepatitis C
• Interventions: Drug: Clinically prescribed direct acting antiviral

• Registration Number: NCT03208244
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Detailed Description

The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Study Start: 2017-11-09
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-28
• Results First Submitted: 2022-05-10
• Results First Submitted QC: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Results First Posted: 2022-06-02
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Recipient is Age ≥ 18 years
• Serum ALT within normal limits with no history of liver disease
• Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection

Exclusion Criteria

• Sensitization (i.e. PRA >20%)
• Any liver disease in recipient
• Albumin < 3g/dl or platelet count < 75 x 103/mL
• Need for dual organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Direct Acting Antiviral for HCV	Clinically prescribed direct acting antiviral	12 weeks of treatment with HCV Direct Acting Antiviral tablet

Primary Outcome Measures

Name	Time	Method
Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment	12 weeks post treatment	Negative HCV viral RNA at 12 weeks after the last dose of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation	12 weeks	Safety and tolerablity of commercially available DAA therapy in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.

Trial Locations

Locations (1)

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