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NCT Number: NCT03145623

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

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Chronic Kidney Diseases Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Kidney Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Caen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Treatment-naïve: Naïve to all anti-HCV treatment
  • Prior interferon or pegylated interferon + ribavirin treatment failure (null responders, partial responders, relapsers)
  • Prior Interferon (IFN) or pegylated (PEG)-IFN + ribavirin + telaprevir or boceprevir or simeprevir treatment failures
  • Prior sofosbuvir based therapy failures
  • 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

Treatment and study plan

Elbasvir and Grazoprevir

Drug

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

Primary outcomes

  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 outcomes

  1. Safety during treatment

    Time frame: during treatment

    Assessment of all Adverse Events and laboratory tests collected during treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • MSD France

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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