NCT03089944

A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.

Conditions

• Hepatitis C Virus (HCV)

Interventions

Type	Name	Description
DRUG	Glecaprevir/Pibrentasvir	Tablet

Timeline

• Start date: 2017-04-28
• Primary completion: 2019-07-31
• Completion: 2019-11-08
• First posted: 2017-03-24
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

113 sites across 19 countries: United States, Bulgaria, Canada, Czechia, France, Greece, Hungary, Ireland, Israel, Italy, Poland, Portugal, Puerto Rico, Romania, Russia, Spain, Taiwan, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study