Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Raymond T. Chung, MD
- Study ID
- NCT03623568
- Phase
- PHASE4
- Status
- Withdrawn
Conditions
- Hepatitis C
- Kidney Diseases
- Kidney Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- glecaprevir/pibrentasvir tablets — DRUG12 weeks of treatment with Mavyret
Study Details
This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Key Dates
- Start date
- Feb 15, 2019
- Status verified
- May 2019
- Primary completion
- Dec 31, 2020
- Completion
- Apr 15, 2021
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV12 weeks of treatment with Mavyret
Primary Outcome Measure
Undetectable HCV RNA in blood [ Time Frame: 12 weeks post treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
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