Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

Phase 4 Completed 10 enrolled Johns Hopkins University Merck Sharp & Dohme LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.

Timeline

Start: 2016-07-20
Primary completion: 2017-05-03
Completion: 2018-01-01

Publications

Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elbasvir	Small molecule	50 mg	Oral
Subject	GRAZOPREVIR ANHYDROUS	Small molecule	100 mg	Oral
Subject	Ribavirin	Small molecule	1000 mg	Oral
Subject	Ribavirin	Small molecule	1200 mg	Oral
Subject	Sofosbuvir	Small molecule	400 mg	—

Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

Summary

Timeline

Publications

Drugs

Indications