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

Conditions

• Hepatitis C Virus (HCV)

Eligibility Criteria

Sex

ALL

Age

3 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Glecaprevir/Pibrentasvir Adult Formulation — DRUG
  Co-formulated film-coated tablet (100 mg/40 mg)
• Glecaprevir + Pibrentasvir Pediatric Formulation — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 20, 2017

Status verified

Apr 2023

Primary completion

May 21, 2020

Completion

Sep 12, 2022

Study Design

Enrollment

129 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Adult Formulation; 12 to < 18 years
  Adolescents aged 12 to \< 18 years old received the adult formulation of glecaprevir (GLE)/pibrentasvir (PIB) 100 mg/ 40 mg co-formulated film-coated tablets for a once daily (QD) total dose of 300 mg/120 mg by mouth for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience.
• Experimental: Cohort 2: Pediatric Formulation; 9 to < 12 years
  Children aged 9 to \< 12 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 9 to \< 12 years old (30 to \< 45 kg) was GLE 200 mg + PIB 75 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 250 mg + PIB 100 mg.
• Experimental: Cohort 3: Pediatric Formulation; 6 to < 9 years
  Children aged 6 to \< 9 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 6 to \< 9 years old (20 to \< 30 kg) was GLE 160 mg + PIB 60 mg. After PK analysis from the first 6 enrolled participants the dose was adjusted to GLE 200 mg + PIB 80 mg.
• Experimental: Cohort 4: Pediatric Formulation; 3 to < 6 years
  Children aged 3 to \< 6 years old received a pediatric formulation of GLE + PIB as small film-coated granules taken with a small amount of food once daily for 8, 12, or 16 weeks depending on HCV genotype, cirrhosis status, and prior treatment experience. The initial proposed dose for children 3 to \< 6 years old (12 to \< 20 kg) was GLE 120 mg + PIB 45 mg. After PK analysis from the first 5 enrolled participants the dose was adjusted to GLE 150 mg + PIB 60 mg.

Primary Outcome Measure

Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir [ Time Frame: Week 2 from predose to 24 hours post-dose ]

Locations (15)

Find similar trials in San Francisco, CA

Related Studies

• Assessing Performance of a Hepatitis C Emergency Department (HepC-EnD) Screening Tool: IT Integration Process for Electronic Health Record System
  Not Yet Recruiting · University of Florida · Gainesville, Florida
• California MEPS Hub
  Recruiting · University of California, Los Angeles · Oakland, California