Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease

Retrospective Efficacy and Safety Study With Elbasvir 50 mg/Grazoprevir 100 mg in HCV-infected Patients With Chronic Kidney Disease Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03145623

Enrollment

100

Registered

2017-05-09

Start date

2017-06-02

Completion date

2017-12-31

Last updated

2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Hepatitis C

Brief summary

Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life

Detailed description

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.

Interventions

DRUGElbasvir and Grazoprevir

Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 2. Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers) 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).

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)	12 weeks after the end of all study therapy	Describe the real life efficacy (Sustained Virologic Response SVR 12) of EBR 50 mg/GZR 100 mg based therapy by assessment of the HCV RNA

Secondary

Measure	Time frame	Description
Safety during treatment	during treatment	Assessment of all Adverse Events and laboratory tests collected during treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026