E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study. |
persistenza della risposta virologica sostenuta in pazienti con epatite cronica C trattati con Alisporivir |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic hepatitis C in patients who achieved sustained virologic response on alisporivir in a previous Novartis-sponsored trial. |
epatite cronica C in pazienti con persistente risposta virologica sostenuta trattati con Alisporivir che hanno partecipato a precedenti protocolli Novartis con alisporivir. |
|
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 | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
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 durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartissponsored chronic Hepatitis C study. |
Obiettivo primario: valutare la persistenza nel tempo della risposta virologica sostenuta nei pazienti che hanno raggiunto l’SVR24 dopo trattamento con alisporivir durante un precedente studio Novartis nell’epatite cronica C. |
|
E.2.2 | Secondary objectives of the trial |
-To determine whether subsequent detection of HCV RNA in patients who relapse following SVR24, represents the re-emergence of preexisting virus, the development of resistance mutations, or whether it is due to re-infection. -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC). -To assess the safety over time of previous alisporivir exposure. |
•Determinare se l’eventuale HCV RNA misurabile nei pazienti che avevano raggiunto l’SVR24 rappresenti una nuova emergenza del virus preesistente oppure sia dovuto allo sviluppo di resistenze o ad una nuova infezione.•Valutare nel tempo le modifiche di malattia epatica nei pazienti che hanno raggiunto l’SVR24 in un precedente studio con alisporivir.•Valutare lo sviluppo di carcinoma epatocellulare•Valutare la sicurezza nel tempo della precedente esposizione del paziente ad alisporivir.Per maggiori dettagli consultare il capitolo 3 del protocollo originale |
|
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 must be aged 18 years or older -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir -Have achieved SVR24 -Be able to comply with visit schedule |
criteri di inclusione principali • 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 • Pazienti che hanno raggiunto l’SVR24 |
|
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 XML File Identifier: K6aU06lo1HleGgyLeCoFO4OY2Zs= Page 10/20 -Use or planned use to start a new course of hepatitis C therapy |
criteri di esclusione principali: • 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 Per maggiori dettagli consultare i paragrafi 5.1 e 5.2 del protocollo originale. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point. |
La variabile di efficacia primaria e' la proporzione dei pazienti che hanno mantenuto la carica virale (HCV RNA) sotto il limite di quantificazione (LOQ: Limit of Quantification) ad ogni valutazione. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the 5 scheduled visits within three years. |
Durante le 5 visite programmate entro 3 anni |
|
E.5.2 | Secondary end point(s) |
-HCV RNA viral load -The proportion of patients who normalize alanine aminotransferase (ALT) -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen -The proportion of relapsed patients -The proportion of re-infected patients -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations |
- Carico virale del RNA di HCV - la percentuale di pazienti che normalizzano l'amminotransferasi alanina (ALT) - valutazioni di fibrosi del fegato facendo uso di Fibrotest e del elastografia e controllo nel tempo per qualsiasi cambiamenti facendo uso dell'ultrasuono del fegato e della milza - la percentuale di pazienti ricaduti - la percentuale di pazienti re-infettati - la valutazione di sicurezza sara' basata sulle analisi degli eventi avversi, delle funzioni vitali e delle valutazioni di laboratorio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the 5 scheduled visits within three years. |
Durante le 5 visite programmate entro 3 anni |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
To assess the durability of sustained virologic response in alisporivir treated |
Valutazione della persistenza della risposta virologica continua nei pazienti trattati con alisporiv |
|
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 | 16 |
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 |
|
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
|
LPLV : 19/JUN/2017 |
LPLV : 19/06/2017 |
|
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 |