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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03208244
Other study ID # 2017P001427
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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