E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019752 |
E.1.2 | Term | Hepatitis C virus (HCV) |
E.1.2 | System Organ Class | 100000004848 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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, including AUC at Week 2 in subjects with intensive pharmacokinetics samples and AUC in all subjects with or without intensive PK samples. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The first interim analysis will occur once all subjects participating in IPK in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects participating in the IPK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A fourth 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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E.5.2 | 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 relapse 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The first interim analysis will occur once all subjects participating in IPK in Part 1 complete PT Week 12 or prematurely discontinue from the study. A second interim analysis will occur once all subjects in Part 1 complete PT Week 12 or prematurely discontinue from the study. A third interim analysis will occur once all subjects participating in the IPK portion in Part 2 complete PT Week 12 or prematurely discontinue from the study. A fourth 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Japan |
Puerto Rico |
Russian Federation |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 8 |