E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies. |
Pazienti con epatite cronica C che non hanno raggiunto la risposta virologica sostenuta durante gli studi con Alisporivir sponsorizzati da Novartis |
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E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C patients who fail to achieve sustained virologic response on alisporivir or direct-acting antivirals in previous Novartissponsored studies. |
Pazienti con epatite cronica che non hanno raggiunto la risposta virologica sostenuta durante gli studi con Alisporivir sponsorizzati da Novartis |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008909 |
E.1.2 | Term | Chronic hepatitis |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
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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 determine the persistence of resistance associated variants associated with failure to previous alisporivir therapy. |
Obiettivo primario: valutare la persistenza delle varianti genotipiche associate alla resistenza e correlate al fallimento della precedente terapia con alisporivir |
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E.2.2 | Secondary objectives of the trial |
-To perform phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro -To monitor the changes in liver function and disease over time -To assess the development of hepatocellular carcinoma (HCC) -To assess the safety over time of previous alisporivir exposure |
Obiettivi secondari principali:•Determinare la suscettibilita'/resistenza dei pazienti ad alisporivir tramite una analisi fenotipica in vitro sugli isolati dell’HCV•Valutare nel tempo le modifiche della funzionalita' epatica e della malattia.•Valutare lo sviluppo di carcinoma epatocellulare•Valutare nel tempo la sicurezza della precedente esposizione del paziente ad alisporivir.Per maggiori dettagli consultare il capitolo 3 del protocollo originale. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Written informed consent must be obtained before any assessment is performed -Males or females aged 18 or greater -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent -Have not acheived SVR24 |
• Donne e uomini maggiorenni che abbiano firmato il consenso informato prima di qualsiasi valutazione prevista dallo studio • Pazienti che hanno partecipato ad un precedente studio sponsorizzato Novartis e hanno ricevuto alisporivir o un farmaco DDA (direct antiviral agent) • Pazienti che non hanno ottenuto l’SVR24 |
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E.4 | Principal exclusion criteria |
-Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer -Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study |
• Pazienti che stanno assumendo altri farmaci sperimentali al momento dell’arruolamento o che li hanno assunti nei 30 giorni precedenti l’inizio dello studio o in un periodo di tempo pari a 5 emivite del farmaco, considerando il periodo piu' lungo • Pazienti che hanno iniziato o si prevede che inizieranno un nuovo ciclo di terapia per l’epatite C nel periodo di tempo successivo alla fine dello studio nell’epatite cronica C sponsorizzato da Novartis Per maggiori dettagli consultare i paragrafi 5.1 e 5.2 del protocollo originale. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to reversion to wild-type for subjects who had genotypic change (resistance associated variants) in the feeder study. |
Nella popolazione costituita da soggetti che hanno avuto una modifica genotipica virale (varianti associate alla resistenza) durante i precedenti studi, il tempo trascorso dalla fine del trattamento dello studio precedente alla perdita della modifica genotipica (per es. il tempo trascorso per la reversione alla condizione genotipica wild-type) sara' valutato mediante il metodo di Kaplan-Meier. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During 11 scheduled visits within three years according to the assessment schedule |
Durante le 11 visite previste entro tre anni secondo il programma di valutazione |
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E.5.2 | Secondary end point(s) |
-HCV RNA viral load -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The assessment of safety will be based on the analyses of adverse events, vital signs and laboratory evaluations |
-HCV RNA carico virale - valutazioni di fibrosi del fegato facendo uso di Fibrotest e dell elastografia e monitoraggio di ogni cambiamento del fegato e della milza col passare del tempo facendo uso dell'ultrasuono - la valutazione della sicurezza sara' basata sulle analisi degli eventi avversi, delle funzioni vitali e delle valutazioni di laboratorio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During 11 scheduled visits within three years according to the assessment schedule |
Durante le 11 visite previste entro tre anni secondo il programma di valutazione |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To assess the viral activity in patients ... |
per valutare l'attivita' virale nei pazienti ... |
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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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 0 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 82 |
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 |
Argentina |
Australia |
Brazil |
Canada |
Egypt |
Hong Kong |
India |
Israel |
Korea, Republic of |
Mexico |
Philippines |
Russian Federation |
Taiwan |
Thailand |
Turkey |
United States |
Vietnam |
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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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LPLV : 19/JUN/2017 |
LPLV : 19/06/2017 |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 59 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 62 |
E.8.9.2 | In all countries concerned by the trial days | 0 |