Hepatitis C Treatment with Glecaprevir and Pibrentasvir – Phase II/III

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 Infection

Protocol Description

The purpose of this multi-center research study is to evaluate the effects of glecaprevir and pibrentasvir in pediatric patients with chronic hepatitis C virus (HCV) infection. Researchers will be measuring the pharmacokinetics – how the body processes the drug combination – as well as effectiveness in treating chronic HCV infection.

Study Level: Phase II/III

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders ages 12 through 17 with chronic HCV genotype 1-6 infection.
Boys and Girls: Ages 3 through 17

Requirements

Potential participants have a screening visit that includes a physical exam, blood work, and other tests to determine eligibility. If eligible, participants will take the study medication once daily for 8, 12, or 16 weeks, depending on their type of HCV infection and other factors. During treatment, participants will return to the clinic for blood tests and other monitoring. After treatment completes, participants will return to the study site for additional monitoring and blood work for about 3 years.
Visits: 11 to 13
Duration: About 3 years

Status: Open to Enrollment

Source(s) of Support

AbbVie

Primary Investigator

Robert H. Squires, Jr. MD

Contact Information

For more information about the study or enrollment, please contact:
Adam D. Kufen, RN, BS, CCRC, MBA
412-692-6558