Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT03496233
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2018-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients
Sponsor:
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Organization:
Study Overview
Official Title:
"Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients With Non-severe Fibrosis, With or Without Glucose Abnormalities - EGG 18"
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGG-18
Brief Summary:
Antiviral treatment of G1b Treatment-Naïve HCV-Infected Patients, with non- severe fibrosis, with or without insulin resistance (IR) and/or diabetes mellitus (DM) with EBR/GZR Fixed-Dose Combination for 8 Weeks.
Detailed Description:
Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Seventy-five (75) treatment-naïve subjects with chronic HCV GT1b infection (without cirrhosis) with or without glucose abnormalities such as insulin resistance and or diabetes will be consecutively enrolled.
The investigators decided to include also patients with glucose abnormalities at baseline screening since data on these patients are scanty, and inclusion of this subgroup of patients better reflects the clinical practice. The study will consecutively enroll patients, without fixing a specific rule (e.g. sample allocation ratio) for recruitment of patients with and without glucose abnormalities. This will allow to evaluate the proportion of patients with and without glucose abnormalities at baseline (a useful approach to understand the impact of patients with glucose abnormalities in real life) and to perform explorative analyses to compare patients with or without glucose abnormalities according to SVR.
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily without regards to food.
Seventy-five (75) treatment-naïve subjects with chronic HCV GT1b infection (without cirrhosis) with or without glucose abnormalities such as insulin resistance and or diabetes will be consecutively enrolled.
The investigators decided to include also patients with glucose abnormalities at baseline screening since data on these patients are scanty, and inclusion of this subgroup of patients better reflects the clinical practice. The study will consecutively enroll patients, without fixing a specific rule (e.g. sample allocation ratio) for recruitment of patients with and without glucose abnormalities. This will allow to evaluate the proportion of patients with and without glucose abnormalities at baseline (a useful approach to understand the impact of patients with glucose abnormalities in real life) and to perform explorative analyses to compare patients with or without glucose abnormalities according to SVR.
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily without regards to food.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: