E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C |
Epatite C cronica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C |
Epatite C cronica |
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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 | LLT |
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 compare rates of SVR12 for Genotype 1 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV. |
Confrontare la percentuale di soggetti con SVR12 per HCV di Genotipo 1 trattati con BMS-790052 o placebo in combinazione con pegIFNα-2a/RBV. |
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E.2.2 | Secondary objectives of the trial |
• To estimate the difference in rates of SVR12 for HCV Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV. • For HCV Genotype 1 or Genotype 4 subjects, assess efficacy. • To assess safety, as measured by the frequency of Serious Adverse Events (SAEs) and discontinuations due to AEs for each cohort. • To assess the relationship between efficacy endpoints and the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene. |
• Valutare la differenza in percentuale della (Sustained Virologic Response) SVR12 per HCV di Genotipo 4 in soggetti trattati con BMS-790052 o placebo in combinazione con pegIFNα-2a/RBV. • Valutare l’efficacia in soggetti con HCV di Genotipo 1 o Genotipo 4. • Valutare la sicurezza, misurata in termini di frequneza di Serious Adverse Events (SAEs) e le interruzioni dovute a eventi avversi (Aes) per ciascuna coorte. • Valutare la relazione tra gli endpoint di efficacia e il polimorfismo del nucleotide singolo rs12979860 (SNP) nel gene IL28B. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects chronically infected with HCV Genotype 1 or 4. • HCV RNA viral load of ≥ 10,000 IU/mL. • No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent. • Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted. |
• Soggetti cronicamente infetti da HCV Genotipo 1 o 4. • HCV RNA carica virale ≥ 10,000 IU/mL. • Nessuna precedente esposizione a un interferone, RBV, o agenti anti-virali diretti per l’HCV. • Risultati di una biopsia epatica ottenuta nei tre anni precedenti l’arruolamento che dimostri l'assenza di cirrosi. Comunque per i soggetti con cirrosi compensata è consentita qualunque precedente biopsia. |
|
E.4 | Principal exclusion criteria |
• Evidence of decompensated liver disease • Documented or suspected HCC • Positive for HBsAg or HIV-1/HIV-2 antibody at screening |
• Evidenza di malattia epatica scompensata • HCC documentato o sospetto • Positivi per HBsAg, HIV-1 o HIV-2 Ab allo screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare rates of SVR12 for HCV Genotype 1 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV. |
Valutare la percentuale di SVR12 per soggetti con HCV Genotipo 1 trattati con BMS-790052 o placebo in combinazione con pegIFNα-2a/RBV |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 12 follow up |
Settimana 12 di follow up |
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E.5.2 | Secondary end point(s) |
1) Proportion of genotype 4 subjects with SVR12 for each cohort 2) Proportion of HCV Genotype 1 or 4 subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ) 3) Proportion of HCV Genotype 1 or 4 subjects who achieve HCV RNA undetectable 4) Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort on treatment 5) Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene. |
1) Percentuale di soggetti con genotipo 4 con SVR12 per ogni coorte
2)Percentuale di soggetti con HCV genotipo 1 o 4 che raggiungono Acido Ribonucleico (RNA) HCV < Limit of quantification (LOQ)
3)Percentuale di soggetti con HCV genotipo 1 o 4 che raggiungono HCV RNA non determinabile
4)Frequenza di Eventi Avversi Gravi (SAEs) e discontinuazioni per Eventi Avversi (AEs) per ciascuna coorte in trattamento
5) Percentuale di soggetti con SVR12 o SVR24 da rs12979860 polimorfismo a singolo nucleotide (SNP) del gene IL28B. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Post-treatment week 12 2) Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] defined as HCV RNA undetectable at weeks 4 and 12 3) Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve VR(4&12) 4) Maximum of 48 weeks 5) Post-treatment week 12 and post treatment week 24. |
1) Settimana 12 di Post-trattamento
2) Settimane 1, 2, 4, 6, 8 e 12; a entrambe le settimane 4 12; EOT (fino a 48 settimane); settimana 24 di post-trattamento (SVR24); o Settimana 48 di post-trattamento per I Soggetti che raggiungono la risposta Virologica alla settimana 4 e 12 [VR(4&12)] definita come HCV RNA non determinabile alle settimane 4 e 12
3) Settimane 1, 2, 4, 6, 8 e 12; ad entrambe le settimane 4 e 12 (VR4&12); EOT; settimana 12 di post-trattamento; settimana 24 di post-trattamento; o settimana 48 di post-trattamento per i soggetti che raggiungono la VR(4&12)
4) Massimo 48 settimane
5) Settimana 12 di post-trattamento e settimana 24 di post trattamento. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
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 |
Brazil |
Canada |
Mexico |
New Zealand |
Russian Federation |
Turkey |
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 | 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 |