E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Liver fibrosis in Subjects with Nonalcoholic Steatohepatitis |
Fibrosi epatica in soggetti affetti da steatoepatite non alcolica |
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E.1.1.1 | Medical condition in easily understood language |
Fatty Liver where the cells in the liver have abnormal fat built-up and built-up of scar tissue in the liver. |
Fegato grasso laddove le cellule del fegato presentano una superficie di grasso e di tessuto cicatriziale superiore alla norma |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053219 |
E.1.2 | Term | Non-alcoholic steatohepatitis |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
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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 objective of this study is to provide open-label treatment with CVC to subjects who have previously participated in CVC studies |
L'obiettivo primario di questo studio è quello di fornire il trattamento in aperto con cenicriviroc (CVC) a soggetti che hanno partecipato in precedenza a studi su CVC |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to assess the long-term safety of continued treatment with CVC for subjects who have previously participated in CVC studies. |
L'obiettivo secondario di questo studio è valutare la sicurezza a lungo termine del trattamento continuato con CVC in soggetti che hanno partecipato in precedenza a studi su CVC |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For a subject to be eligible for participation in this study, all of the following criteria must apply.
1. Successfully completed both Treatment Period 1 and Treatment Period 2, per protocol, of the CENTAUR study (652-2-203), including a Year 2 liver biopsy 2. Must provide a signed written informed consent form 3. Females of child-bearing potential and males participating in the study must agree to use at least 2 approved barrier methods of contraception throughout the duration of the study and for 3 months after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for = 12 months and serum follicle stimulating hormone (FSH) = 30 mU/mL |
Per il soggetto che sia idoneo alla partecipazione a questo studio, devono essere applicati tutti i seguenti criteri: 1. Completamento del periodo di trattamento 1 e del periodo di trattamento 2 dello studio CENTAUR (652-2-203), compresa una biopsia del fegato all'anno 2 2. Firma del modulo di consenso informato scritto 3. I soggetti di sesso maschile e i soggetti di sesso femminile in età fertile che partecipano allo studio devono acconsentire a utilizzare almeno 2 metodi barriera di contraccezione approvati per l'intera durata dello studio e per 3 mesi dopo l'interruzione del farmaco dello studio. Le donne in post-menopausa devono presentare interruzione documentata del ciclo mestruale da = 12 mesi e un livello di ormone follicolostimolante sierico (FSH) = 30 mU/ml. |
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E.4 | Principal exclusion criteria |
A subject will not be eligible for participation in this study if any of the following criteria apply. 1. Any clinically significant change in the subject’s medical history or condition which, in the opinion of the investigator, would preclude administration of open-label CVC, including laboratory tests 2. Prior or planned liver transplantation 3. Other known causes of chronic liver disease, such as the following: • Alcoholic liver disease • Primary biliary cirrhosis • Primary sclerosing cholangitis • Autoimmune hepatitis • Wilson’s disease, hemochromatosis, or iron overload • Alpha-1-antitrypsis (A1AT) deficiency 4. Females who are pregnant or breastfeeding 5. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements. |
Un soggetto non sarà idoneo alla partecipazione a questo studio se si applica uno dei seguenti criteri: 1. Qualsiasi variazione clinicamente significativa nell'anamnesi medica o nelle condizioni del soggetto che, secondo il parere dello sperimentatore, impedirebbe la somministrazione di CVC in aperto, incluse analisi di laboratorio 2. Trapianto di fegato precedente o pianificato 3. Altre cause note di epatopatia cronica, quali: • Epatopatia alcolica • Cirrosi biliare primitiva • Colangite sclerosante primitiva • Epatite autoimmune • Malattia di Wilson, emocromatosi o sovraccarico di ferro • Deficit di alfa-1 antitripsina (A1AT) 4. Donne in gravidanza o in allattamento al seno 5. Qualsiasi altro disturbo clinicamente significativo o terapia precedente che, secondo il parere dello sperimentatore, renderebbe il soggetto non idoneo allo studio o non in grado di rispettare i requisiti di somministrazione e del protocollo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Long-term safety assessment of CVC administration |
Valutazione di sicurezza a lungo termine della somministrazione di CVC |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Once Cenicriviroc is commercially available or if development is discontinued |
Una volta che Cenicriviroc è disponibile in commercio o se lo sviluppo viene interrotto |
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E.5.2 | Secondary end point(s) |
Safety assessments including adverse events, hematology profile, chemistry profile, coagulation profile and serum chemistry |
Valutazioni di sicurezza tra cui eventi avversi, profilo ematologico, profilo chimico, profilo di coagulazione e chimica sierica |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline, and every 3 months thereafter until study discontinued |
Iniziale, e isuccessivamente ogni 3 mes¿ fino alla discontinuazione dello studio |
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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 | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
E.8.1.2 SI -In Aperto (non selezionabile per malfunzionamento del sistema) |
|
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 28 |
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 | Information not present in EudraCT |
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 |
Australia |
Hong Kong |
United States |
Belgium |
France |
Germany |
Italy |
Poland |
Spain |
United Kingdom |
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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
|
When the drug product becomes commercially available or if the study is discontinued by the Sponsor |
Quando il farmaco verrà commercializzato o lo studio sarà interrotto dallo Sponsor |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |