A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

Completed · Phase 2/Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to \< 12 years.

Key facts

Study ID

NCT03067129

Run by

AbbVie

People needed

129

Starts

2017-03-20

Expected to finish

2022-09-12

Last updated by the study team

2023-05-09

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 International Unit (IU)/mL
• Subjects participating in the intense pharmacokinetic (IPK) part must have been HCV treatment-naive, with or without compensated cirrhosis (Child-Pugh A), human immunodeficiency virus type 1 (HIV-1) negative and must have had a Screening laboratory result indicating HCV genotype (GT) 1, 2, 3, 4, 5, or 6-infection.

You may not qualify if…

• Females who were pregnant or breastfeeding
• Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus deoxyribonucleic acid (DNA)
• Participants with other known liver diseases
• Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child-Pugh class B or C cirrhosis

Where it is running

• Univ of California San Francis /ID# 158002 — San Francisco, California, United States
• Childrens Hospital Colorado /ID# 157996 — Aurora, Colorado, United States
• CT Childrens Medical Ctr, US /ID# 158639 — Hartford, Connecticut, United States
• UF Hepatology Research at CTRB /ID# 158008 — Gainesville, Florida, United States
• Advent Health /ID# 166022 — Orlando, Florida, United States
• Indiana University /ID# 158001 — Indianapolis, Indiana, United States
• Boston Childrens Hospital /ID# 157988 — Boston, Massachusetts, United States
• Boston Medical Center /ID# 157997 — Boston, Massachusetts, United States
• Columbia Univ Medical Center /ID# 158000 — New York, New York, United States
• UNC Health Care /ID# 157991 — Chapel Hill, North Carolina, United States
• Cincinnati Childrens Hosp Med /ID# 158007 — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia /ID# 158003 — Philadelphia, Pennsylvania, United States
• Child Hosp of Pittsburgh,PA /ID# 158004 — Pittsburgh, Pennsylvania, United States
• Monroe-Carell Jr. Children's H /ID# 169037 — Nashville, Tennessee, United States
• Baylor College of Medicine /ID# 157989 — Houston, Texas, United States
• Cliniques Universitaires Saint Luc /ID# 162173 — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• UZ Leuven /ID# 162174 — Leuven, Belgium
• Alberta Children's Hospital /ID# 163449 — Calgary, Alberta, Canada
• Stollery Children's Hospital /ID# 163450 — Edmonton, Alberta, Canada
• Hospital for Sick Children /ID# 163448 — Toronto, Ontario, Canada
• Universitatsklinikum Freiburg /ID# 165187 — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Charite Universitaetsmedizin Berlin /ID# 165186 — Berlin, Germany
• Helios Klinikum Wuppertal /ID# 165185 — Wuppertal, Germany
• Kurume University Hospital /ID# 165718 — Kurume-shi, Fukuoka, Japan
• Osaka General Medical Center /ID# 212745 — Osaka, Osaka, Japan

Full record on ClinicalTrials.gov

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