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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03208244
• Other study ID #: 2017P001427
• Status: Terminated
• Phase: Phase 4
• Start date: November 9, 2017
• Est. completion date: April 28, 2021

Study information

• Verified date: June 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: April 28, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Heart Disease
• Heart Diseases
• Hepatitis
• Hepatitis C

Intervention

Drug:
• Clinically prescribed direct acting antiviral
HCV treatment for 12 weeks

Locations

Country	Name	City	State
United States	Masschusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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