Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
M16-123
Description
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.
Trial arms
Trial start
2017-03-20
Estimated PCD
2020-05-21
Trial end
2022-09-12
Status
Completed
Phase
Early phase I
Treatment
Glecaprevir/Pibrentasvir Adult Formulation
Co-formulated film-coated tablet (100 mg/40 mg)
Arms:
Cohort 1: Adult Formulation; 12 to < 18 years
Other names:
ABT-493/ABT-530, MAVYRET®
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.
Arms:
Cohort 2: Pediatric Formulation; 9 to < 12 years, Cohort 3: Pediatric Formulation; 6 to < 9 years, Cohort 4: Pediatric Formulation; 3 to < 6 years
Other names:
ABT-493/ABT-530
Size
129
Primary endpoint
Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir
Week 2 from predose to 24 hours post-dose
Steady-state AUC0-24 of Pibrentasvir
Week 2 from predose to 24 hours post-dose
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
12 weeks after last dose of study drug (Week 20, 24, or 28 depending on treatment duration)
Eligibility criteria
Inclusion Criteria: * Hepatitis C virus (HCV) infection demonstrated by positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 International Unit (IU)/mL * Subjects participating in the intense pharmacokinetic (IPK) part must have been HCV treatment-naive, with or without compensated cirrhosis (Child-Pugh A), human immunodeficiency virus type 1 (HIV-1) negative and must have had a Screening laboratory result indicating HCV genotype (GT) 1, 2, 3, 4, 5, or 6-infection. Exclusion Criteria: * Females who were pregnant or breastfeeding * Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus deoxyribonucleic acid (DNA) * Participants with other known liver diseases * Decompensated cirrhosis defined as: presence of ascites, history of variceal bleeding, lab values consistent with Child-Pugh class B or C cirrhosis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 129, 'type': 'ACTUAL'}}
Updated at
2023-05-09

1 organization

1 product

1 indication

Organization
AbbVie
Product
Glecaprevir + Pibrentasvir
Indication
Hepatitis C Virus