Hepatitis C Clinical Trial
Official title:
Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
Verified date | August 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 16, 2020 |
Est. primary completion date | June 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Recipient Inclusion Criteria: - Met MGH transplant center criteria and already listed for kidney transplant - Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method - No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team - Able to sign informed consent Recipient Exclusion Criteria: - Pregnant or nursing (lactating) women - HBV positivity (Ag or DNA) - Any contra-indication to kidney transplantation per center protocol Donor Inclusion Criteria - Detectable HCV NAT test - KDPI score is less than = 0.850 - Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Donor Exclusion Criteria - Confirmed HIV - Confirmed HBV positive (surface antigen or HBV DNA positive) - Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Undetectable HCV RNA | Negative HCV RNA 12 weeks after last dose of treatment | 12 weeks post-treatment | |
Primary | Rate of Serious and non-serious adverse events | Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment | 1 year post-transplant |
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