A Study to Evaluate ABT-493/ABT-530 in the Treatment of Hepatitis C Virus Infection in Children

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004102-34-ES

Enrollment

100

Registered

2017-06-09

Start date

2017-08-25

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection MedDRA version: 20.0 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV) System Organ Class: 100000004848

Interventions

Product Name: Glecaprevir/Pibrentasvir Product Code: ABT-493/ABT-530 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Glecaprevir Current Sponsor code: ABT-493 Other descriptive name: GLEC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hepatitis C Virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV Ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL. 2. Subject must have a weight consistent with a recommended weight range for their age at the time of screening. Subjects that fall out of the weight band for their age at the time of screening may be screened only into the safety and efficacy parts of the study upon TA MD approval. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Females who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for HBV DNA. 3. Participants with other known liver diseases. 4. Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child's class B or C cirrhosis.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the steady state AUC and to assess the pharmacokinetics (PK) of ABT-493/ABT-530 in pediatric subjects by age group and to evaluate the safety and tolerability of ABT-493/ABT-530 by age group, cirrhosis status and across all subjects.;Secondary Objective: The secondary objectives are to assess the efficacy of ABT-493/ABT-530 by assessing the percentage of subjects with sustained virologic response for 12 weeks post treatment (SVR12) in HCV GT1 – 6 infected pediatric subjects, the percentages of subjects with on-treatment HCV virologic failure, the percentages of subjects with post-treatment HCV relapse and the percentages of subjects with new HCV infection (or re-infection) for each age group and overall. Also to assess pharmacokinetics and emergence/persistence of viral variants in subjects with available samples; and assess palatability of pediatric formulation, Cmax and clearance of GLE and PIB.;Primary end point(s): The primary pharmacokinetic endpoint will be steady state AUC of ABT-493 and ABT-530 estimated by non-compartmental pharmacokinetic analysis or population pharmacokinetic analysis.;Timepoint(s) of evaluation of this end point: An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study.	—

Measure

Time frame

Main Objective: The primary objective is to assess the steady state AUC and to assess the pharmacokinetics (PK) of ABT-493/ABT-530 in pediatric subjects by age group and to evaluate the safety and tolerability of ABT-493/ABT-530 by age group, cirrhosis status and across all subjects.;Secondary Objective: The secondary objectives are to assess the efficacy of ABT-493/ABT-530 by assessing the percentage of subjects with sustained virologic response for 12 weeks post treatment (SVR12) in HCV GT1 – 6 infected pediatric subjects, the percentages of subjects with on-treatment HCV virologic failure, the percentages of subjects with post-treatment HCV relapse and the percentages of subjects with new HCV infection (or re-infection) for each age group and overall. Also to assess pharmacokinetics and emergence/persistence of viral variants in subjects with available samples; and assess palatability of pediatric formulation, Cmax and clearance of GLE and PIB.;Primary end point(s): The primary pharmacokinetic endpoint will be steady state AUC of ABT-493 and ABT-530 estimated by non-compartmental pharmacokinetic analysis or population pharmacokinetic analysis.;Timepoint(s) of evaluation of this end point: An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study.

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Secondary

Measure	Time frame
Secondary end point(s): The main secondary endpoint is Cmax and clearance of ABT-493 and ABT-530. The secondary efficacy endpoints are the percentage of subjects with SVR12, the percentage of subjects with on-treatment virologic failure, the percentage of subjects with post treatment relaspe and the percentage of subjects with new HCV infection at any time up to the last study visit. These will be summarized overall and by age group.;Timepoint(s) of evaluation of this end point: An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study.	—

Measure

Time frame

Secondary end point(s): The main secondary endpoint is Cmax and clearance of ABT-493 and ABT-530. The secondary efficacy endpoints are the percentage of subjects with SVR12, the percentage of subjects with on-treatment virologic failure, the percentage of subjects with post treatment relaspe and the percentage of subjects with new HCV infection at any time up to the last study visit. These will be summarized overall and by age group.;Timepoint(s) of evaluation of this end point: An interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects participated in the intensive PK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects in Parts 1 and 2 complete PT Week 12 or prematurely discontinue the study. Final analysis will occur after the completion of the whole study.

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Countries

Belgium, Canada, Germany, Japan, Puerto Rico, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd.

abbvie_reec@abbvie.com+34901 200 103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026