Transplanting Hepatitis C Lungs Into Negative Lung Recipients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2022

Conditions
Lung Diseases
Interventions
DRUG

Zepatier

Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.

DRUG

Epclusa

Epclusa (sofosbuvir 400mg and velpatasvir 100mg once daily) is taken by mouth for 12 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.

Trial Locations (1)

19104

Hospital of the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of Pennsylvania

OTHER

NCT03724149 - Transplanting Hepatitis C Lungs Into Negative Lung Recipients | Biotech Hunter | Biotech Hunter