Phase 3
Completed N=64
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT02486406 ↗
Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Oct 2021
Primary outcomePrimary: Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV) — 99.6; 116; 83.7 ng/mL
◆ Published Evidence
Emerging
12citations · ~2 / year
Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a.
Summary
This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.
Linked Publications
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Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir Mini-Tabs Plus Ribavirin for Children Aged 3-11 Years with Hepatitis C Genotype 1a.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Maximum Plasma Concentration (Cmax) of Ombitasvir (OBV) |
99.6; 116; 83.7 | — |
| PRIMARY Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ombitasvir (OBV) |
1270; 1490; 1060 | — |
| PRIMARY Part 1: Lowest Plasma Concentration (Ctrough) of Ombitasvir (OBV) |
24.7; 28.2; 21.8; 29.6; 30.4; 20.9 | — |
| PRIMARY Part 1: Maximum Plasma Concentration (Cmax) of Paritaprevir (PTV) |
294; 1540; 870 | — |
| PRIMARY Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Paritaprevir (PTV) |
2180; 8640; 5770 | — |
| PRIMARY Part 1: Lowest Plasma Concentration (Ctrough) of Paritaprevir (PTV) |
9.86; 16.1; 18.0; 17.3; 18.4; 23.5 | — |
| PRIMARY Part 1: Maximum Plasma Concentration (Cmax) of Dasabuvir (DSV) |
579; 830; 671 | — |
| PRIMARY Part 1: Concentration of Drug in Blood Plasma Against Time [Area Under the Curve (AUC)] of Dasabuvir (DSV) |
3960; 5960; 4630 | — |
| PRIMARY Part 1: Lowest Plasma Concentration (Ctrough) of Dasabuvir (DSV) |
110; 215; 165; 168; 264; 191 | — |
| PRIMARY Part 1: Maximum Plasma Concentration (Cmax) of Ritonavir (RTV) |
1090; 1830; 1180 | — |
| PRIMARY Part 1: Concentration of Drug in Blood Plasma Over Time [Area Under the Curve (AUC)] of Ritonavir (RTV) |
6570; 14100; 8900 | — |
| PRIMARY Part 1: Lowest Plasma Concentration (Ctrough) of Ritonavir (RTV) |
16.1; 32.1; 29.8; 91.8; 38.1; 58.2 | — |
| PRIMARY Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) |
98.4 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Last Actual Dose of Study Drug (SVR12) Summarized by Formulation, Age and Weight Group, and Across All Subjects on the Adult Formulations |
100; 100; 100; 100; 92.9; 96.2 | — |
| SECONDARY Parts 1 & 2: Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Actual Dose of Study Drug (SVR24), Summarized by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations |
96.9; 100; 100.0; 88.9; 100.0; 92.9 | — |
| SECONDARY Parts 1 and 2: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization During Treatment by Formulation, Age and Weight Group, Across All Subjects, and Across All Subjects on the Adult Formulations |
87.5; 100; 100; 80.0; 87.5; 87.5 | — |
Eligibility Criteria
Inclusion Criteria
- Positive anti-hepatitis C virus antibody (HCV Ab) and HCV ribonucleic acid (RNA) ≥ 1000 IU/mL at the time of screening
- HCV genotype 1 for enrollment into Part 1 of the study and genotype 1 or 4 for enrollment into Part 2
- Parent or legal guardian with the willingness and ability to provide written informed consent and participant willing and able to give assent, as appropriate for age and country
Exclusion Criteria
- Female participant who is pregnant, breastfeeding or is considering becoming pregnant
- Use of known strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving dasabuvir, or strong or moderate inducers of CYP3A, within 2 weeks or 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
- Positive test result for Hepatitis B surface antigen (HbsAg) or anti-human immunodeficiency virus antibody (HIV Ab) test
- Current enrollment in another interventional clinical study, previous enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than interferons or ribavirin or receipt of any investigational product within 6 weeks prior to study drug administration
Data sourced from ClinicalTrials.gov (NCT02486406) 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.