Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

PHASE4CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

August 20, 2019

Study Completion Date

March 5, 2020

Conditions
Renal Failure
Interventions
DRUG

elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT02945150 - Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant | Biotech Hunter | Biotech Hunter