NCT03212521

Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotypes 1 - 6 Infection and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

Conditions

• Hepatitis C Virus (HCV)

Interventions

Type	Name	Description
DRUG	Glecaprevir/Pibrentasvir	Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.

Timeline

• Start date: 2017-08-07
• Primary completion: 2018-08-13
• Completion: 2018-08-13
• First posted: 2017-07-11
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

42 sites across 10 countries: United States, Bulgaria, Canada, France, Germany, Poland, Puerto Rico, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study