Hepatitis C Treatment with Elbasvir and Grazoprevir – Phase IIb

Study to Assess the Combination Regimen of Elbasvir/Grazoprevir in Pediatric Participants With Chronic Hepatitis C Infection

Protocol Description

The purpose of this multi-center research study is to evaluate the effects of elbasvir taken in combination with grazoprevir (EBR/GZR) in children and teens with chronic hepatitis C virus (HCV) infection. Researchers will be measuring the pharmacokinetics – how the body processes the drug combination – as well as side effects and the effectiveness in treating chronic HCV infection.

Study Level: Phase IIb

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders ages 3 through 17 with chronic HCV genotype (GT)1 or GT4 infection.
Boys and Girls: Ages 3 through 17

Requirements

Participants will take EBR/GZR in tablet form once a day, or in granules mixed with soft food for younger participants. Except for the first dose, which will be done at the study site, all doses can be taken at home. Approximately every four weeks, participants will visit the study site for a physical and other tests, including blood draws and review of the study medication and a meal diary that participants (or their parents) will update.
Visits: 14
Duration: About 43 weeks

Status: Enrollment Pending

Source(s) of Support

Merck

Primary Investigator

Robert H. Squires, MD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN
412-692-8453