Hepatitis C Clinical Trial
Official title:
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Verified date | June 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Masschusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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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