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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145623
• Other study ID #: RC31/17/0096
• Status: Completed
• Phase: N/A
• First received: April 25, 2017
• Last updated: February 13, 2018
• Start date: June 2, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hepatitis C
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Caen
France	University Hospital Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	MSD France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety during treatment	Assessment of all Adverse Events and laboratory tests collected during treatment	during treatment