Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Toulouse
With
MSD France
Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)\* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
documented chronic (at least 6 months) HCV Genotype1 (GT1) and Genotype 4 (GT4) infection
Mono infected by HCV or co-infected by HCV and HIV
Have an HCV treatment status corresponding to one of the following:
1. Treatment-naïve: Naïve to all anti-HCV treatment
3. Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
4. Prior sofosbuvir based therapy failures
5. Pegylated interferon ribavirin intolerant
Have CKD defined as:
Subjects with glomerular filtration rate (GFR) ≤30 ml/min who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).
You may not be if
none
Clareo Health | Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease
