E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic HCV Genotype 1-6 Infection. |
Infezione cronica da Virus dell’Epatite C di Genotipo 1 – 6. |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Virus Infection. |
Infezione cronica da Virus dell’Epatite C. |
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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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To assess the virologic response to 12 weeks of treatment with ABT- 493/ABT-530 by determining the percentage of subjects who achieved a sustained virologic response at 12 weeks post-treatment (SVR12) and to evaluate safety of ABT-493/ABT-530 in adults with chronic HCV genotype 1 – 6 infection with chronic renal impairment. |
Valutare la risposta virologica a 12 settimane di trattamento con ABT493/ABT-530 determinando la percentuale di soggetti che raggiungono una risposta virologica sostenuta a 12 settimane dopo il trattamento (SVR12) e valutare la sicurezza di ABT-493/ABT-530 in soggetti adulti affetti da infezione cronica da HCV di genotipo 1 – 6 e da compromissione renale cronica. |
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E.2.2 | Secondary objectives of the trial |
● The percentages of subjects with on-treatment virologic failure; ● The percentages of subjects with post-treatment relapse; ● To assess pharmacokinetics of ABT-493/ABT-530 and the emergence and persistence of viral variants in this treatment regimen. |
• La percentuale di soggetti che manifestano fallimento virologico in corso di trattamento; • La percentuale di soggetti con recidiva post-trattamento; • Valutare la farmacocinetica di ABT-493/ABT-530 e la presenza e persistenza delle varianti virali in questo regime di trattamento. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Amd. 1-Wed Sep 16 00:00:00 CEST 2015-Optional pharmacogenetic.-Pharmacogenetics. Pharmacokinetics.16/09/2015.Amd 1. |
Amd. 1-Wed Sep 16 00:00:00 CEST 2015-Optional pharmacogenetic.-Pharmacogenetics. Optional pharmacokinetic. |
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E.3 | Principal inclusion criteria |
1. Male or female at least 18 years of age at time of Screening. 2. Screening laboratory result indicating chronic HCV GT1-6 infection. 3. Subject must be HCV treatment-naïve or have received prior HCV treatment with IFN or pegIFN with or without RBV, pegIFN/RBV plus SOF, or SOF plus RBV. 4. Subject must have chronic renal impairment (CKD stage 4 or 5). |
1. Soggetti di ambo i sessi e di età pari o superiore a 18 anni al momento dello Screening. 2. Soggetti con infezione cronica da HCV di genotipo 1-6 confermato da analisi di laboratorio allo Screening. 3. Soggetti naïve al trattamento anti-HCV o soggetti che abbiano ricevuto trattamento anti-HCV pregresso con IFN o pegIFN con o senza RBV, pegIFN/RBV + SOF, o SOF + RBV. 4. Soggetti con pre-esistente compromissione renale cronica (CKD stadio 4 o 5) |
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E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any excipients of the study drug. 2. Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study. 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. 4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). 5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype. |
1. Soggetti con storia di sensibilità grave, potenzialmente fatale o altrimenti significativa a qualsiasi eccipiente del medicinale sperimentale. 2. Soggetti di sesso femminile in stato di gravidanza, che intendono incominciare una gravidanza durante il periodo della sperimentazione o che stanno allattando, o soggetti di sesso maschile le cui partner sono in stato di gravidanza o intendono iniziare una gravidanza durante il periodo della sperimentazione. 3. Storia recente (nei 6 mesi precedenti la somministrazione del medicinale sperimentale) di abuso di sostanze stupefacenti o di alcolici che a giudizio dello sperimentatore impedirebbe l’aderenza al protocollo. 4. Positività allo Screening per l’antigene di superficie dell’epatite B (HBsAg) o per l’anticorpo al virus dell’immunodeficienza umana (HIV Ab). 5. Risultati del test eseguito durante lo screening per rilevare il genotipo HCV che indica la presenza di co-infezione con più di un genotipo del virus HCV. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of subjects with SVR 12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug). |
Percentuale di soggetti con SVR12 (HCV RNA < LLOQ 12 settimane dopo l’ultima dose di medicinale sperimentale effettivamente somministrata). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drug. |
12 settimane dopo l’ultima dose di medicinale sperimentale. |
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E.5.2 | Secondary end point(s) |
* The percentage of subjects with on treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment); * The percentage of subjects with post-treatment relapse (defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequencing). |
• La percentuale di soggetti che manifestano fallimento virologico in corso di trattamento (definito come aumento confermato di almeno 1 log10 UI/mL rispetto al nadir durante il trattamento, conferma di livelli di HCV RNA ≥ 100 successivamente a riscontri di HCV RNA < LLOQ in corso di trattamento oppure HCV RNA ≥ LLOQ alla fine del trattamento della durata di almeno 6 settimane); • La percentuale di soggetti con recidiva post-trattamento (definita come livelli confermati di HCV RNA ≥ LLOQ nell’intervallo compreso fra la conclusione del trattamento e 12 settimane dopo l’ultima dose del medicinale sperimentale nei soggetti che hanno portato a termine il trattamento come da programma e che presentano livelli di HCV RNA < LLOQ alla fine del trattamento; con ulteriore suddivisione tra i soggetti con recidiva rispetto ai reinfetti basata sul sequenziamento della popolazione con HCV). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
* Start of treatment (Day 1) until End of Treatment. * 12 weeks after end of treatment |
• Inizio del Trattamento (Giorno 1) fino alla fine del trattamento; • 12 settimane dopo l’ultima dose di medicinale sperimentale. |
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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 | No |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
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 | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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.8.3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Information not present in EudraCT |
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 |
Australia |
Belgium |
Canada |
France |
Greece |
Italy |
New Zealand |
United Kingdom |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |