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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04320290
Other study ID # 2020P000374
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date May 21, 2020
Est. completion date June 16, 2020

Study information

Verified date August 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.


Recruitment information / eligibility

Status Withdrawn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)

Study Design


Intervention

Drug:
Direct Acting Antivirals
8 weeks of DAA treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome

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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