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

Completed · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

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.

Key facts

Study ID

NCT03212521

Run by

AbbVie

People needed

230

Starts

2017-08-07

Expected to finish

2018-08-13

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
• Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
• Does not have current active hepatitis B virus infection defined as:
• positive hepatitis B surface antigen (HBsAg), OR
• hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
• Platelets ≥ 150,000 cells/mm³
• Albumin ≥ lower limit of normal (LLN)
• Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
• No past history/evidence of cirrhosis.
• No history of hepatocellular carcinoma.
• Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
• If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Where it is running

• Parkway Medical Center /ID# 161261 — Birmingham, Alabama, United States
• Arkansas Gastroenterology /ID# 161266 — North Little Rock, Arkansas, United States
• UC Davis Medical Center /ID# 161138 — Sacramento, California, United States
• Yale University /ID# 161258 — New Haven, Connecticut, United States
• Univ Maryland School Medicine /ID# 161157 — Baltimore, Maryland, United States
• Digestive Disease Associates - Baltimore /ID# 161260 — Baltimore, Maryland, United States
• University of Michigan Hospitals /ID# 161265 — Ann Arbor, Michigan, United States
• Northwest Gastroenterology Cli /ID# 161257 — Portland, Oregon, United States
• Liver Associates of Texas, P.A /ID# 161262 — Houston, Texas, United States
• University of Vermont Medical Center /ID# 161263 — Burlington, Vermont, United States
• Digestive and Liver Disease Sp /ID# 161259 — Norfolk, Virginia, United States
• DCC Aleksandrovska /ID# 161340 — София, Sofia, Bulgaria
• DCC Mladost M /ID# 161339 — Varna, Bulgaria
• South Health Campus /ID# 161385 — Calgary, Alberta, Canada
• The Moncton Hospital /ID# 161384 — Moncton, New Brunswick, Canada
• Brampton Civic Hospital /ID# 161380 — Brampton, Ontario, Canada
• Toronto Liver Centre /ID# 161381 — Toronto, Ontario, Canada
• Hopital Saint Joseph /ID# 161571 — Marseille, Bouches-du-Rhone, France
• CHU de Rennes - PONTCHAILLOU /ID# 161492 — Rennes, Brittany Region, France
• CHU de Besancon - Jean Minjoz /ID# 161485 — Besançon, Doubs, France
• Hopitaux de Brabois Adultes /ID# 161482 — Vandœuvre-lès-Nancy, Lorraine, France
• Universitätsklinikum Frankfurt /ID# 161397 — Frankfurt am Main, Hesse, Germany
• Universitaetsmedizin der Johannes-Gutenberg Universität Mainz /ID# 161396 — Mainz, Rhineland-Palatinate, Germany
• Charité Universitätsmedizin Campus Mitte /ID# 161395 — Berlin, Germany
• ICH Study Center GmbH & Co KG /ID# 161394 — Hamburg, Germany

Full record on ClinicalTrials.gov

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