CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 129 enrolled
Drug / intervention
Glecaprevir/Pibrentasvir Adult Formulation +1 moredrug
Likely dose
Glecaprevir/Pibrentasvir Adult Formulation 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03067129
NCT03067129Phase 3Completed
CompareCT.gov

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

AbbVie·interventional·Posted Mar 1, 2017·Updated May 9, 2023

In Brief

A Phase 3 clinical trial evaluating Glecaprevir/Pibrentasvir Adult Formulation and Glecaprevir + Pibrentasvir Pediatric Formulation for Hepatitis C Virus (HCV). Completed, enrolled 129 participants across 38 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
CountriesBelgium, Canada, Germany, Japan, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 1, 2017
Enrollment StartMar 20, 2017
Primary CompletionMay 21, 2020
Study CompletionSep 12, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.3 years ago

Interventions

Glecaprevir/Pibrentasvir Adult Formulationdrug

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

Glecaprevir + Pibrentasvir Pediatric Formulationdrug

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.