E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic HCV Genotype 1 Infection |
Infezione Cronica da Virus dell’Epatite C di Genotipo 1 |
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E.1.1.1 | Medical condition in easily understood language |
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 show the non-inferiority in SVR12 rates (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [HCV RNA < LLOQ 12 weeks following therapy]) after 12 weeks of treatment with the combination regimen ABT-493/ABT-530 to the historical SVR rate established by current approved standard of care regimens for GT1 (ombitasvir/ paritaprevir/ritonavir + dasabuvir ± RBV or SOF/LDV for 12 weeks). |
Dimostrare la non inferiorità dei tassi SVR12 (percentuale di soggetti che ottengono la risposta virologica sostenuta a 12 settimane, SVR12 [HCV RNA < LLOQ 12 settimane dopo la terapia]) dopo 12 settimane di trattamento con il regime combinato ABT-493/ABT-530 rispetto al tasso storico di SVR ottenuto dai regimi dello standard di cura attualmente approvati per il genotipo 1 (ombitasvir/paritaprevir/ritonavir + dasabuvir ± RBV oppure SOF/LDV per 12 settimane). |
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E.2.2 | Secondary objectives of the trial |
To show the non-inferiority in SVR12 rates of the ABT-493/ABT-530 regimen for 8 weeks versus 12 weeks of treatment. |
Dimostrare la non inferiorità dei tassi di SVR12 del regime ABT-493/ABT-530 per il trattamento della durata di 8 settimane rispetto al trattamento della durata di 12 settimane. |
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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 |
Original-Tue Jun 16 00:00:00 CEST 2015-Optional pharmacogenetic.-Pharmacogenetics. Optional pharmacokinetic. |
Original-Tue Jun 16 00:00:00 CEST 2015-Farmacogenetica optional.-Farmacogenetica. Farmacocinetica optional. |
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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 HCV GT1 infection. 3. Chronic HCV infection. 4. Subject must be HCV DAA treatment-naïve 5. 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. Risultato di laboratorio allo screening che conferma infezione da HCV di genotipo 1. 3. Infezione cronica da HCV. 4. Soggetti naïve al trattamento anti-HCV con DAA 5. Soggetti non affetti da cirrosi. |
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E.4 | Principal exclusion criteria |
1. History of severe, life-threatening or other significant sensitivity to any component 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. Storia di sensibilità grave, potenzialmente fatale o altrimenti significativa a qualsiasi eccipiente dei medicinali sperimentali 2. Soggetto di sesso femminile che è in stato di gravidanza o intende incominciare una gravidanza durante il periodo della sperimentazione o che sta allattando, o soggetto di sesso maschile la cui partner è in stato di gravidanza o intende 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 SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) in each arm. |
Percentuale di soggetti con SVR12 (HCV RNA < LLOQ 12 settimane dopo l’ultima dose del medicinale sperimentale) in ciascun braccio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks following the last dose of study drug. |
12 settimane dopo l’ultima dose del medicinale sperimentale. |
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E.5.2 | Secondary end point(s) |
• The percentage of subjects with on-treatment virologic failure; • 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 |
● the percentage of subjects with on-treatment virologic failure (defined as confirmed increase of > 1 log10 IU/mL above nadir during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment), and ● 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 with HCV RNA < LLOQ at the end of treatment; with further breakdown by relapse versus reinfection based on HCV population sequence). |
• La percentuale di soggetti che manifestano fallimento virologico durante il trattamento (definito come un aumento confermato di > 1 log10 IU/mL sul nadir durante il trattamento, o HCV RNA≥ LLOQ alla fine del trattamento con almeno 6 settimane di trattamento) • La percentuale di soggetti con recidiva post trattamento (definita come HCV RNA ≥ LLOQ confermato, tra la fine del trattamento e 12 settimane dopo l’ultima dose di medicinale sperimentale tra i soggetti che hanno completato il trattamento con HCV RNA < LLOQ alla fine del trattamento, con un’ulteriore suddivisione in base a recidiva versus reinfezione mediante sequenziamento di popolazione HCV). |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Diversa durata stesso trattamento, dati storici ombit./paritapr./riton. ± RBV o sofos./ledispav. |
Same treatment different duration, historical data ombit./paritapr./riton. ± RBV or sofos./ledispav. |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 66 |
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 |
Canada |
Chile |
Israel |
Korea, Republic of |
Mexico |
New Zealand |
Puerto Rico |
Russian Federation |
Switzerland |
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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |