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

Completed

• Conditions: Chronic Kidney Diseases; Hepatitis C

• Registration Number: NCT03145623
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Study Start: 2017-06-02
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety during treatment	during treatment	Assessment of all Adverse Events and laboratory tests collected during treatment

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Caen, France

University Hospital Toulouse; 🇫🇷 Toulouse, France