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Eligibility
for people ages 3–17
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults. Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.

Official Title

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

Keywords

Hepatitis C Virus (HCV) Compensated (Child-Pugh A) cirrhosis Treatment naïve pegylated interferon (pegIFN) Ribavirin (RBV) Chronic Hepatitis C Virus Treatment experienced Interferon (IFN) Pharmacokinetic Non-cirrhotic cirrhosis Glecaprevir sofosbuvir Pibrentasvir Interferons

Eligibility

You can join if…

Open to people ages 3–17

  • 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.
  • Subject must have a weight consistent with a recommended weight range for their age at the time of screening.

You CAN'T join if...

  • 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's class B or C cirrhosis.

Locations

  • Childrens Hospital Colorado /ID# 157996 not yet accepting patients
    Aurora, Colorado, 80045-7106, United States
  • Children's Hospital of Pittsburgh, Pennsylvania /ID# 158004 not yet accepting patients
    Pittsburgh, Pennsylvania, 15224, United States
  • UF Hepatology Research at CTRB /ID# 158008 not yet accepting patients
    Gainesville, Florida, 32610-0272, United States
  • UNC School of Medicine /ID# 157991 not yet accepting patients
    Chapel Hill, North Carolina, 27599, United States
  • The Children's Hospital of Philadelphia (CHOP) /ID# 158003 not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • Columbia University /ID# 158000 not yet accepting patients
    New York, New York, 10032, United States
  • Boston Childrens Hospital /ID# 157988 not yet accepting patients
    Boston, Massachusetts, 02115, United States
  • Boston Medical Center /ID# 157997 not yet accepting patients
    Boston, Massachusetts, 02118, United States
  • San Jorge Children Hospital /ID# 160850 accepting new patients
    San Juan, 00912, Puerto Rico

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03067129
Phase
Phase 3
Study Type
Interventional
Last Updated
April 1, 2017
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