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Summary

This is a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics, efficacy,and safety of glecaprevir (GLE)/pibrentasvir (PIB) for 8, 12, or 16 weeks in Hepatitis C virus (HCV) genotype 1-6 (GT1 - GT6)-infected pediatric participants ≥ 3 to < 18 years of age, with or without compensated cirrhosis, with or without human immunodeficiency virus (HIV) coinfection, who were either treatment-naïve (TN), treatment-experienced (TE) with pegylated interferon (pegIFN) with or without ribavirin (RBV), or TE with sofosbuvir (SOF) + RBV with or without pegIFN. The study was divided into 2 parts, according to the formulation of GLE/PIB administered. Part 1 of the study enrolled HCV GT1 - GT6 infected adolescent participants into the ≥ 12 to < 18 years old age group who were willing to swallow the adult formulation of GLE/PIB (Cohort 1). Part 2 of the study enrolled HCV GT1 - GT6 infected pediatric participants divided into the ≥ 9 to < 12 (Cohort 2), ≥ 6 to < 9 (Cohort 3), and ≥ 3 to < 6 (Cohort 4) years old age groups, who received the pediatric formulation of GLE + PIB. Interim data are presented for all participants in Parts 1 and 2 who completed post-treatment Week 12 or prematurely discontinued from the study.

Conditions

Hepatitis C Virus (HCV)

Recruitment Status

Active, not recruiting

Eligibility Criteria

Inclusion Criteria:

- Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL

Exclusion Criteria:

Females who are pregnant or breastfeeding
Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV 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

Intervention

Intervention Type

Intervention Name

Drug

Glecaprevir/pibrentasvir adult formulation

Drug

Glecaprevir/pibrentasvir pediatric formulation

Phase

Phase 2, Phase 3

Gender

All

Min Age

3 Years

Max Age

17 Years

Download Date

June 23, 2022

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: