Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
NCT03625687 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2023-04-25
Summary
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Conditions
- Respiratory Failure
- Hepatitis C
Interventions
- DRUG
-
Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Raymond T Chung, MD · Massachusetts General Hospital
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-05
- Primary Completion
- 2022-04-04
- Completion
- 2022-04-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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