Summary

for people ages 3-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Philip Rosenthal

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

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

  • Univ of California San Francis /ID# 158002 accepting new patients
    San Francisco California 94158 United States
  • Children's and Women's Health Centre of British Columbia Branch /ID# 163934 not yet accepting patients
    Vancouver British Columbia V6H 3V4 Canada

Lead Scientist

Details

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