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

February 13, 2018 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • University Hospital
      • Toulouse, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CKD subjects with GT1 and GT4 HCV, compensated cirrhotic or non-cirrhotic (i.e all subjects with EBR 50 mg/GZR 100 mg based therapy in ATU allocation) will be included in this retrospective analysis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)
Time Frame: 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
12 weeks after the end of all study therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety during treatment
Time Frame: during treatment
Assessment of all Adverse Events and laboratory tests collected during treatment
during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

MSD France

Investigators

  • Principal Investigator: Laurent ALRIC, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/17/0096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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