Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
NCT03093740 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2018-12-20
Summary
Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
Conditions
- Renal Failure Chronic
- Hepatitis C
Interventions
- DRUG
-
Zepatier
Based on negative viral resistance testing of the donor treatment will be Zepatier
- DRUG
-
Zepatier plus Sofosbuvir
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Raymond Chung, MD · Massachusetts General Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2020-12-31
- Completion
- 2021-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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