NCT03496233

Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients

"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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic HCV Hepatitis

Interventions

Type	Name	Description
DRUG	Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]	Treatment with EBR/GZR Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients, with non- severe fibrosis, with or without IR and/or DM

Timeline

• Start date: 2018-09-19
• Primary completion: 2020-05-20
• Completion: 2020-06-20
• First posted: 2018-04-12
• Last updated: 2023-02-22

Locations

1 site across 1 country: Italy