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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03145623
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
MSD France
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Hepatitis C Chronic Kidney Diseases Drug: Elbasvir and Grazoprevir

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Intervention Details:
  • Drug: Elbasvir and Grazoprevir
    Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety during treatment [ Time Frame: during treatment ]
    Assessment of all Adverse Events and laboratory tests collected during treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145623


Locations
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France
University Hospital
Caen, France, 14000
University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
MSD France
Investigators
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Principal Investigator: Laurent ALRIC, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03145623    
Other Study ID Numbers: RC31/17/0096
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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MK-5172
Hepatitis C
Kidney Diseases
Renal Insufficiency, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Urologic Diseases
Renal Insufficiency
Antiviral Agents
Anti-Infective Agents