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

Study Overview
=================
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.

Official Title
-----------------
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant

Conditions
-----------------
End Stage Heart Disease, Hepatitis C

Intervention / Treatment
-----------------
* Drug: Clinically prescribed direct acting antiviral


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Received heart transplant from HCV+ donor
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Direct Acting Antiviral for HCV<br>12 weeks of treatment with HCV Direct Acting Antiviral tablet | Drug: Clinically prescribed direct acting antiviral<br>* HCV treatment for 12 weeks<br>* Other names: DAA treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment | Negative HCV viral RNA at 12 weeks after the last dose of treatment. | 12 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation | 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Disease, Heart Transplant, HCV, Hepatitis C