Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients (EGG-18)
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|ClinicalTrials.gov Identifier: NCT03496233|
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic HCV Hepatitis||Drug: Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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"|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: All patients included
All patients included will be treated with Elbasvir/grazoprevir for 8 weeks
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
- Efficacy of elbasvir/grazoprevir fixed dose combination for 8 weeks in genotype 1b treatment naive HCV infected patients. [ Time Frame: at 12 weeks ]Proportion of subject with sustained viral response (SVR) 12 weeks after cessation of treatment in G1b treatment naive HCV infected patients, with non severe fibrosis, with or without IR and/or DM treated with elbasvir/grazoprevir fixed dose combination for 8 weeks.
- Incidence of treatment emergent adverse events (safety and tolerability). [ Time Frame: 12 weeks after cessation of treatment ]Number (percentage) of participants with treatment related adverse events.
- Insulin resistance [ Time Frame: 12 weeks ]• Assessments of insulin resistance were measured using HOMA-IR at baseline and follow-up week (FW)12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496233
|Contact: Vincenza Calvarusoemail@example.com|
|Policlinico Paolo Giaccone||Not yet recruiting|
|Palermo, Italy, 90127|
|Contact: Vincenza Calvaruso, MD, PHD firstname.lastname@example.org|