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

NCT03145623 | Completed

• 1 other identifier: RC31/17/0096
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatitis C; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Efficacy of Elbasvir (EBR)/Grazoprevir (GZR)

  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 Outcomes (1)

• Safety during treatment

  during treatment

Interventions

Elbasvir and Grazoprevir DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• MSD France: collaborator

Study Sites (2)

University Hospital

Caen, 14000, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hepatitis C; Renal Insufficiency, Chronic

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurent ALRIC, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 9, 2017
• Study Start: June 2, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)