Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
NCT03627299 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2021-10-19
Summary
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 4 weeks post-renal transplant.
Conditions
- End Stage Renal Disease
- Hepatitis C
Interventions
- DRUG
-
300mg glecaprevir/pibrentasivir 120mg
300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Christine Durand, MD · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-25
- Primary Completion
- 2019-12-19
- Completion
- 2021-09-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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