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

Completed · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

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.

Key facts

Study ID

NCT03089944

Run by

AbbVie

People needed

343

Starts

2017-04-28

Expected to finish

2019-11-08

Last updated by the study team

2020-07-13

Who can join

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

You may qualify if…

• Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
• Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
• Treatment-naive to any approved or investigational anti-HCV medication.
• Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

You may not qualify if…

• Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
• Any current or historical clinical evidence of decompensated cirrhosis.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
• HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
• History of suspected or confirmed hepatocellular carcinoma.

Where it is running

• Mayo Clinic Arizona /ID# 162314 — Phoenix, Arizona, United States
• Liver Wellness Center /ID# 162244 — Little Rock, Arkansas, United States
• Felizarta /ID# 162295 — Bakersfield, California, United States
• VA Long Beach Healthcare System /ID# 162298 — Long Beach, California, United States
• Usc /Id# 162248 — Los Angeles, California, United States
• Kaiser Permanente - San Diego (Palm Ave) /ID# 162289 — San Diego, California, United States
• Stanford University School of Med /ID# 162209 — Stanford, California, United States
• Cedars-Sinai Medical Center - West Hollywood /ID# 162313 — West Hollywood, California, United States
• University of Miami /ID# 162210 — Miami, Florida, United States
• Triple O Research Institute /ID# 162300 — West Palm Beach, Florida, United States
• Piedmont Hospital /ID# 162646 — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 162208 — Chicago, Illinois, United States
• Unity Point Health /ID# 162247 — Des Moines, Iowa, United States
• The University of Iowa Hospita /ID# 162214 — Iowa City, Iowa, United States
• University of Louisville /ID# 162242 — Louisville, Kentucky, United States
• Louisiana Research Ctr. LLC /ID# 162567 — Shreveport, Louisiana, United States
• Mercy Medical Center /ID# 162291 — Baltimore, Maryland, United States
• Mayo Clinic - Rochester /ID# 162251 — Rochester, Minnesota, United States
• Southern Therapy and Advanced Research (STAR) LLC /ID# 162241 — Jackson, Mississippi, United States
• CHI Health Alegent Creighton /ID# 162286 — Omaha, Nebraska, United States
• Univ Nebraska Med Ctr /ID# 162285 — Omaha, Nebraska, United States
• Rnjms /Id# 162213 — Newark, New Jersey, United States
• Weill Cornell Medical College /ID# 161051 — New York, New York, United States
• Icahn School of Med Mt. Sinai /ID# 162294 — New York, New York, United States
• St. Josephs Hosp and Med Ctr /ID# 162762 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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