E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HCV active infection at the time of OLT
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trapianto epatico in paziente con infezione HCV-correlata attiva |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C virus active infection at the time of liver's trasplant |
trapianto epatico in paziente con infezione del virus dell'epatite C attiva |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 if the administration of a combination of GS 7977 and ribavirin to post-OLT HCV subjects for 24 weeks can prevent post-transplant HCV re-infection as determined by a sustained post-transplant virological response (HCV RNA <LLoQ) at 12 weeks post-transplant |
L’obiettivo primario dello studio è valutare se la somministrazione della combinazione GS 7977 (Sovaldi®) e Ribavirina nell’immediato post-operatorio a pazienti sottoposti a trapianto per malattia epatica HCV-correlata può prevenire la reinfezione del graft definite come risposta virologica sostenuta (SVR) (HCV RNA <LLoQ) a 12 settimane post-trapianto |
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E.2.2 | Secondary objectives of the trial |
• Effect of treatment on HCV-related liver disease histology at 1-year
• To evaluate the HCV RNA viral kinetics during the initial treatment phase (2 weeks, 4 weeks, 8 weeks) and correlation with response rate
Evaluate, from the perspective of the Italian NHS, the overall healthcare cost of the pre-emptive treatment with sofosbuvir and ribavirin of post- LT HCV patients during the observational period. The collectionof these data will allow to compare, in a descriptive way, these costs vs those of patients, with similar characteristics, treated according the current routine practice.
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• Effetto del trattamento sul quadro istologico epatico ad 1 anno dal trapianto
• Cinetica di HCV RNA durante le fasi iniziali del trattamento e sua correlazione con il tasso di risposta e breaktrough
• Valutare i costi associati al trattamento dei pazienti nel periodo di osservazione nella prospettiva del Servizio Sanitario Nazionale. La rilevazione dei dati permetterà di confrontare, secondo una modalità descrittiva, i costi sostenuti per il trattamento pre-emptive con sofosbuvir/ribavirina rispetto ai costi di trattamento secondo l’attuale pratica clinica di pazienti con caratteristiche simili. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males or females, age > 18 years old
-All transplant patients with HCV active infection at the time of OLT
-All genotypes
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Maschi o femmine, di età> 18 anni
-Tutti i pazienti trapiantati con HCV infezione attiva al momento della OLT
Tutti i genotipi |
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E.4 | Principal exclusion criteria |
-Patients unable to receive oral therapy
-< 6 months from previous DAA treatment
-CrCl <30ml/min (MDRD or CKD-EPI)
-HIV and/or HBV coinfection
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-I pazienti non in grado di ricevere una terapia orale
- <6 mesi dal precedente trattamento DAA
- CrCl <30 ml / min (MDRD o CKD-EPI)
- HIV e / o HBV coinfezione |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Post-treatment sustained virological response (pTVR): SVR12 |
Risposta virologica sostenuta post-trattamento alla settimana 12 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
•Post-treatment sustained virological response (pTVR): SVR24;
•Histology at 1-year post-OLT
•Healthcare resource consumption due to drug treatments, diagnostic services, specialist visits, lab tests, hospitalisations)
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•Risposta virologica sostenuta post-trattamento (pTVR): SVR24;
Istologia epatica ad 1 anno post-trapianto
•Consumo di risorse per le prestazioni assistenziali erogate ai pazienti (terapia farmacologica, test diagnostici, visite specialistiche, analisi di laboratorio, ospedalizzazioni)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | 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 | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |