Phase 3
Completed N=127
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
Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT03067129 ↗
Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir — 4790; 7870; 6860; 7520 ng*h/mL
◆ Published Evidence
Highly cited
109citations · ~18 / year
Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study.
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.
Linked Publications (3)
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Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study.
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Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Children With Chronic HCV: Part 2 of the DORA Study.
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Population Pharmacokinetic Analysis of Glecaprevir and Pibrentasvir in Pediatric Patients ≥ 3 to < 18 Years of Age with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady-state Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of Glecaprevir |
4790; 7870; 6860; 7520 | — |
| PRIMARY Steady-state AUC0-24 of Pibrentasvir |
1380; 2200; 1640; 1790 | — |
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) |
100; 93.1; 100; 95.8; 96.3; 97.6 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Glecaprevir |
1040; 1370; 1600; 1530 | — |
| SECONDARY Apparent Clearance (CL/F) of Glecaprevir From Plasma |
62.6; 31.8; 29.1; 19.9 | — |
| SECONDARY Maximum Plasma Concentration of Pibrentasvir |
174; 225; 197; 233 | — |
| SECONDARY Apparent Clearance of Pibrentasvir From Plasma |
86.9; 45.4; 48.7; 33.6 | — |
| SECONDARY Percentage of Participants Who Experienced On-treatment Virologic Failure |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse up to 12 Weeks Post Treatment |
0; 3.6; 0; 0; 1.3; 0.8 | — |
| SECONDARY Percentage of Participants With New Hepatitis C Virus Infection (Reinfection) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Palatability Questionnaire Question 1: How Convenient or Inconvenient Was it to Prepare the Dose? |
7; 9; 9; 25; 13; 10 | — |
| SECONDARY Palatability Questionnaire Question 2: How Long Did it Typically Take for the Child to Take the Dose? |
22; 23; 21; 66; 5; 4 | — |
| SECONDARY Palatability Questionnaire Question 3: Were You Able to Successfully Administer the Whole Dose to the Child With 1 to 2 Teaspoons (5 to 10 mL) of Soft Food? |
20; 19; 19; 58; 8; 8 | — |
| SECONDARY Palatability Questionnaire Question 4: Did You Experience Any Resistance When Feeding the Child the Medicine? |
6; 4; 7; 17; 22; 23 | — |
| SECONDARY Palatability Questionnaire Question 4a: Type of Feeding Resistance |
3; 5; 6; 14; 2; 2 | — |
| SECONDARY Palatability Questionnaire Question 5: How Easy or Difficult Was it for the Child to Swallow the Medicine? |
10; 8; 11; 29; 13; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT03067129) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.