E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Hepatitis C Infection and compensated cirrhosis. |
Infezione Cronica da Virus dell’Epatite C e cirrosi compensata. |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Hepatitis C Infection and early liver damage. |
Infezione Cronica da Virus dell’Epatite C e danno epatico allo stadio iniziale. |
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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 | 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 |
The primary objectives of this study are to assess efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) and safety of coformulated ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 12 or 24 weeks in HCV genotype 1-infected adults with compensated cirrhosis. |
Gli obiettivi primari di questa sperimentazione sono rappresentati dalla valutazione dell'efficacia (percentuale di soggetti che ottengono una risposta virologica sostenuta a 12 settimane SVR12 (HCV RNA < limite inferiore di quantificazione (LLOQ) 12 settimane dopo il trattamento) e della sicurezza di ABT-450, ritonavir e ABT-267 in co-formulazione (ABT-450/r/ABT-267) e ABT-333 in co-somministrazione con RBV per 12 o 24 settimane in adulti con infezione da HCV di genotipo 1 con cirrosi compensata. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the rapid virologic response rate (RVR) (the percentage of subjects with HCV RNA < LLOQ at Week 4), the end of treatment response (EOTR) rate (the percentage of subjects with HCV RNA < LLOQ at Week 12 for the 12-week arm or at Week 24 for the 24-week arm) and compare SVR12 between the two arms. |
Gli obiettivi secondari di questa sperimentazione sono la valutazione del tasso di risposta virologica rapida (rapid virologic response rate - RVR) (percentuale di soggetti con HCV RNA < LLOQ alla Settimana 4), del tasso di risposta alla fine del trattamento (end of treatment response rate - EOTR) (percentuale di soggetti con HCV RNA < LLOQ alla Settimana 12 per il braccio di 12 settimane o alla Settimana 24 per il braccio di 24 settimane), e del confronto delle SVR12 fra i due bracci. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males or females 18 - 70 years old, inclusive -Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control -Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 10,000 IU/mL at screening -Subject has either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond -Documentation of cirrhosis (Child Pugh A) |
• Soggetti di ambo i sessi e di età compresa fra 18 e 70 anni, inclusi • Donne in post-menopausa per più di 2 anni o chirurgicamente sterili o che pratichino metodi contraccettivi specifici • Presenza di infezione cronica da HCV di genotipo 1 (livelli di HCV RNA > 10.000 UI/mL allo Screening) • Soggetti che non abbiano mai ricevuto trattamenti antivirali per l’epatite C o che siano stati precedentemente trattati con pegIFN/RBV e non rispondano al trattamento. • Cirrosi documentata (Child-Pugh A). |
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E.4 | Principal exclusion criteria |
-Positive screen for drugs or alcohol -Significant sensitivity to any drug -Use of contraindicated medications within 2 weeks of dosing -Abnormal laboratory tests -Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody |
• Screening positivo per abuso di droghe o alcool • Sensibilità significativa a qualsiasi farmaco • Uso di farmaci controindicati entro 2 settimane dal trattamento • Risultati di laboratorio alterati • Positività all'antigene di superficie per l'Epatite B o agli anticorpi per il virus dell’Immunodeficienza umana |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the percentage of subjects with SVR12. |
L’endpoint primario di efficacia è rappresentato dalla percentuale di soggetti con SVR12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after last dose of study drug. |
12 Settimane dopo l’ultima dose di farmaco sperimentale. |
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E.5.2 | Secondary end point(s) |
1. The percentage of subjects with rapid virologic response (HCV RNA < LLOQ at Week 4); 2. The percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment) 3. The comparison of the percentage of subjects with SVR12 between the two arms. |
1. Percentuale di soggetti con risposta virologica rapida (HCV RNA < LLOQ alla Settimana 4) 2. Percentuale di soggetti con risposta alla fine del trattamento (HCV RNA < LLOQ alla fine del trattamento 3. Confronto della percentuale di soggetto con SVR12 fra i due bracci |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 4 weeks after the first dose of study drug; 2. 12 or 24 weeks after the first dose of study drug. 3. 12 weeks after the last dose of study drug for the 12 week arm and 24 weeks after the last dose of study drug for the 24 week arm. |
1. 4 settimane dopo la prima dose di farmaco sperimentale; 2. 12 o 24 settimane dopo la prima dose di farmaco sperimentale. 3. 12 settimane dopo l’ultima dose di farmaco sperimentale per il braccio di 12 settimane e 24 settimane dopo l’ultima dose di farmaco sperimentale per il braccio di 24 settimane. |
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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) | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
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 |
Canada |
Puerto Rico |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 18 |
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 | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |