E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HEPATITIS C VIRUS |
Infezione cronica da Epatite C |
|
E.1.1.1 | Medical condition in easily understood language |
HEPATITIS C VIRUS |
Infezione cronica da Epatite C |
|
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 | 15.0 |
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 |
The purpose of this study is to estimate efficacy, as determined by the
proportion of subjects with SVR12, defined as HCV RNA < LOQ at posttreatment
Week 12, for subjects who are prior null or partial responders
to P/R or who are treatment-naive. |
Stimare l’efficacia, determinata dalla proporzione di soggetti con SVR12 , definita come HCV RNA < LOQ alla Settimana 12 post trattamento, per i soggetti che non hanno risposto o hanno risposto in modo parziale a precedente terapia con P/R o naive al trattamento. |
|
E.2.2 | Secondary objectives of the trial |
• Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ
at post-treatment Week 12, for subjects who are intolerant or ineligible
to P/R;
• On treatment safety, as measured by frequency of SAEs and
discontinuations due to AEs through the end of treatment plus 7 days; |
• Proporzione di soggetti trattati con SVR12, definita come RNA < LOQ alla Settimana 12 post trattamento per i soggetti che sono Intolleranti o Ineleggibili a P/R;
• Sicurezza durante il trattamento, misurata dalla frequenza di Eventi Avversi Seri (SAEs) e dalle interruzioni dovute ad Eventi Avversi (AEs) fino alla fine del trattamento più 7 giorni. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and females, ≥ 18 years of age;
• HCV Genotype 1b who previously failed treatment with peginterferon
alfa and ribavirin, classified as previous null or partial responders based
on previous therapy, OR intolerant or ineligible to P/R due to
neutropenia, anemia, depression or thrombocytopenia with cirrhosis, OR
treatment naive;
• HCV RNA ≥ 104 IU/mL (10,000 IU/mL);
• Seronegative for HIV and HBsAg;
• Subjects with compensated cirrhosis are permitted (compensated
cirrhotics are capped at approximately 25% of treated population). |
• Maschi e Femmine > 18 anni;
• Soggetti con HCV Genotipo 1b che hanno fallito un precedente trattamento con Peginteferone alfa e Ribavirina, classificati come precedente Null o Partial Responders (soggetti che Non Hanno Risposto o che hanno Risposto in modo Parziale) sulla base della precedente terapia OPPURE Intolleranti o Ineleggibili a P/R a causa di neutropenia, anemia, depressione o trombocitopenia con cirrosi OPPURE soggetti naive al trattamento;
• HCV RNA > 104 IU/mL (10.000 IU/mL);
• Sieronegativo per HIV e HbsAg;
• Sono consentiti soggetti con cirrosi compensata (limitati a circa il 25% della popolazione trattata |
|
E.4 | Principal exclusion criteria |
• Prior treatment of HCV with HCV direct acting antiviral (DAA);
• Evidence of a medical condition contributing to chronic liver disease other than HCV;
• Evidence of decompensated liver disease including, but not limited to,
a history or presence of ascites, bleeding varices, or hepatic
encephalopathy;
• Diagnosed or suspected hepatocellular carcinoma or other malignancies;
• Uncontrolled diabetes or hypertension; |
• Precedente esposizione a qualsiasi HCV DAA;
• Evidenza di condizioni mediche che favoriscano malattia epatica cronica diversa dall’ HCV;
• Evidenza di malattia epatica scompensata incluso, ma non limitato a, storia o presenza di ascite, varici sanguinanti o encefalopatia epatica;
• Diagnosi o sospetto di Carcinoma epatocellulare o altri tumori;
• Diabete non controllato o ipertensione |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at
post-treatment Week 12, for all subjects who are prior null or partial
responders to P/R or are treatment-naive |
Proporzione di soggetti trattati che abbiano SVR12, definita come HCV RNA < LOQ alla Settimana 12 di follow-up, per soggetti che Non hanno Risposto o hanno Risposto in Modo Parziale a P/R o per i soggetti Naive al trattamento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 12 weeks post-treatment |
Settimana 12 successiva al trattamento |
|
E.5.2 | Secondary end point(s) |
• Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ
at post-treatment Week 12, for subjects who are intolerant or ineligible
to P/R;
• On treatment safety, as measured by frequency of SAEs and
discontinuations due to AEs through the end of treatment plus 7 days; |
• Proporzione di soggetti trattati che abbiano SVR12, definita come HCV RNA < LOQ alla Settimana 12 di follow-up, per soggetti che sono Intolleranti o Ineleggibili a P/R;
• Sicurezza durante il trattamento, misurata dalla frequenza di Eventi Avversi Seri (SAEs) e dalle interruzioni dovute ad Eventi Avversi (AEs) fino alla fine del trattamento più 7 giorni |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Post-treatment Week 12;
• Through the end of treatment (maximum of 48 weeks) plus 7 days; |
• Alla Settimana 12 post-trattamento;
• Fino alla fine del trattamento (massimo 48 settimane) più 7 giorni |
|
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 | No |
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 |
Open and single group for Null/partial responder and |
Open and single group for Null/partial responder and |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 |
Israel |
Korea, Republic of |
New Zealand |
Russian Federation |
Singapore |
Taiwan |
United States |
|
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
|
The last visit will be considered the date of the last post-treatment
visit. |
La data dell’ultima visita di post.trattamento verrà considerata ulttima visita |
|
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 | 28 |
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 | 28 |
E.8.9.2 | In all countries concerned by the trial days | 0 |