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Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03496233
Study type Interventional
Source Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Contact Vincenza Calvaruso
Phone 0916552280
Status Not yet recruiting
Phase Phase 3
Start date April 2018
Completion date December 2018