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An Open-label, Non-randomized Pilot Study to Determine the Safety and Efficacy of Two Weeks of Fixed-dose Glecaprevir and Pibrentasvir as Pre- and Post-exposure Prophylactic Therapy
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment. The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 2 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Johns Hopkins Hospital
Baltimore, Maryland, United States
Start Date
November 20, 2020
Primary Completion Date
November 28, 2023
Completion Date
December 1, 2023
Last Updated
January 10, 2024
10
ACTUAL participants
Glecaprevir/pibrentasvir
DRUG
Lead Sponsor
Johns Hopkins University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT04163614