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

NCT03067129 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2023-05-09

Study results available
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Summary

The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in children ages 3 to \< 12 years.

Conditions

  • Hepatitis C Virus (HCV)

Interventions

DRUG

Glecaprevir/Pibrentasvir Adult Formulation

Co-formulated film-coated tablet (100 mg/40 mg)

DRUG

Glecaprevir + Pibrentasvir Pediatric Formulation

Film-coated pellets/granules (15.67%/8.25%) administered by mixing with a small amount (1-2 teaspoons) of a soft food vehicle, such as hazelnut spread, Greek yogurt, or peanut butter.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2020-05-21
Completion
2022-09-12
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Japan
  • Puerto Rico
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067129 on ClinicalTrials.gov