E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic HCV Infection |
Infezione Cronica da HCV |
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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 |
The primary objectives of this study are to assess the efficacy (SVR12) HCV RNA < lower limit of quantification (LLOQ) 12 weeks following 12 weeks of treatment of the ABT-493/ABT-530 combination regimen and the safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen compared to placebo, in adults with chronic HCV genotype (GT) 2 infection without underlying cirrhosis. |
Gli obiettivi primari di questa sperimentazione sono la valutazione dell’efficacia (SVR12) HCV RNA < limite inferiore di quantificazione (LLOQ) 12 settimane dopo la fine di un trattamento con il regime combinato ABT-493/ABT-530 della durata di 12 settimane, e valutazione rispetto a placebo della sicurezza di 12 settimane di trattamento con il regime combinato ABT-493/ABT-530 in soggetti adulti affetti da infezione cronica da HCV di genotipo 2 in assenza di cirrosi di base. |
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E.2.2 | Secondary objectives of the trial |
The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with on-treatment virologic failure during the Double-Blind Treatment Period. The percentage of subjects treated with the ABT-493/ABT-530 combination regimen with post-treatment relapse following the Double-Blind Treatment Period. |
La percentuale di soggetti che manifestano fallimento virologico durante il trattamento per i pazienti che ricevono ABT-493/ABT-530 nell’ambito del Periodo di Trattamento in Doppio Cieco; La percentuale di soggetti con recidiva post-trattamento dopo la conclusione del Periodo di Trattamento in Doppio Cieco per i pazienti trattati con ABT-493/ABT-530. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female at least 18 years of age at time of screening. - Screening laboratory result indicating HCV GT2 infection. - Chronic HCV infection. - Subject must be HCV treatment-naïve or has failed prior IFN or pegIFN with or without RBV, or SOF plus RBV with or without PegIFN therapy. - Subjects must be non-cirrhotic. |
1. Soggetti di ambo i sessi e di età pari o superiore a 18 anni al momento dello screening. 2. Soggetti con infezione da HCV di genotipo 2 confermato da analisi di laboratorio allo Screening. 3. Infezione cronica da HCV. 4. Soggetti naïve al trattamento anti-HCV o che abbiano fallito una precedente terapia con IFN o pegIFN con o senza RBV, o SOF più RBV con o senza pegIFN. 5. Soggetti non affetti da cirrosi. |
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E.4 | Principal exclusion criteria |
- History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs. - 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. - 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. - Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). - 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 dei medicinali sperimentali. 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 primary efficacy endpoint is the percentage of subjects with SVR12. |
L’endpoint primario di efficacia è rappresentato dalla percentuale di soggetti che ottengono la risposta SVR12. |
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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 la somministrazione dell’ultima dose di medicinale sperimentale. |
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E.5.2 | Secondary end point(s) |
- The percentage of subjects with virologic failure during treatment. - The percentage of subjects with post-treatment relapse. |
- La percentuale di soggetti che manifestano fallimento virologico durante il trattamento - La percentuale di soggetti con recidiva post-trattamento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- At The end of treatment (last dose of study drug in The trial) |
- Dal giorno di fine trattamento (dopo l’ultima dose del farmaco in studio) |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
12 settimane in doppio cieco seguite da 12 settimane in aperto per soggetti randomizzati a placebo. |
12 week double-blind followed by 12 week open label for subjects initially randomized to placebo. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Korea, Republic of |
Taiwan |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 3 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 3 |