E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic HCV hepatitis, all fibrosis |
epatite cronica da HCV, tutte le fibrosi |
|
E.1.1.1 | Medical condition in easily understood language |
hepatitis C virus infection |
infezione da virus dell'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 | 20.1 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019755 |
E.1.2 | Term | Hepatitis chronic active |
E.1.2 | System Organ Class | 10019805 - Hepatobiliary disorders |
|
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 |
1.To improve knowledge on the prevalence of HCV infection in a hidden population, such as that of illegal, foreign refugees or asylum seekers politicoin an area of southern Italy. These subjects are indeed at high risk of infection by HCV date the origin from high endemic areas for HCV infection. 2. To evaluate the clinical, biochemical and virological subjects anti-HCV positive results. 3. Get a sustained virologic response in all subjects anti-HCV / HCV-RNA positive identified, thanks to a combination regimen of anti-HCV drugs pangenotipica (sofosbuvir / velpatasvir) for 12 weeks |
1. Migliorare la conoscenza sulla prevalenza dell'infezione da HCV in una popolazione sommersa, quale quella degli stranieri irregolari, rifugiati o richiedenti asilo politicoin un'area del sud italia. Tali soggetti sono infatti ad alto rischio d'infezione da HCV data la proveniebza da zone ad alta endemia per infezione da HCV. 2. Valutare le caratteristiche cliniche, biochimiche e virologiche dei soggetti risultati anti-HCV positivi. 3. Ottenere una risposta virologica sostenuta in tutti i soggetti anti-HCV/HCV-RNA positivi identificati,grazie ad un regime di combinazione di farmaci anti-HCV pangenotipica (sofosbuvir/velpatasvir) per 12 settimane
|
|
E.2.2 | Secondary objectives of the trial |
Identifying the demographic and behavioral factors associated with positive anti-HCV in the immigrant population studied with the help of cultural mediators who speak not only English, franese, as expected from previous research program, but also Arabic, Somali and other African languages. 2. Tell the studied population health rules to be adopted to reduce the transmission of HCV, after administration of a questionnaire to assess the degree of perception of the problem by spreading an information booklet has been translated into English, French and Arabic. 3. perform a screening of the partners of irregular migrants, asylum seekers and refugees anti_HCV positive about the possibility of a sexual and familial transmission of these infections. 4. Identify factors riischio associated with the non-response to treatment with sofosbuvil + velpatasvir in this population.
|
1. Identificare i fattori demografici e comportamentali associati alla positività di anti-HCV nella popolazione di immigrati studiati mediante l'ausilio di mediatori culturali che parlano non solo l'inglese, il franese, come previsto dal precedente programma di ricerca, ma anche l'arabo, il somalo e altre lingue africane. 2. Indicare alla popolazione studiata norme sanitarie da adottare per ridurre la trasmissione di HCV, previa somministrazione di un questionario per valutare il grado di percezione del problema, diffondendo un opuscolo informativo tradotto in inglese, francese ed arabo. 3.Screenare i conviventi di immigrati irregolari , richiedenti asilo e rifugiati anti_HCV positivi per l'eventualità di una trasmissione sessuale e familiare di tali infezioni. 4. Identificare fattori di riischio associati alla non-risposta al trattamento con sofosbuvil+velpatasvir in tale popolazione. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects illegal immigrants, refugees or asylum seekers in Italy for at least three months, observed for the first time or already known from our center, with HCV infection and who have signed informed consent |
Soggetti immigrati irregolari, rifugiati o richiedenti asilo, in Italia da almeno 3 mesi, osservati per la prima volta o già conosciuti dal nostro centro, affetti da epatite cronica C e che abbiano firmato il consenso informato |
|
E.4 | Principal exclusion criteria |
Subjects indigenous or registered refugees |
Soggetti autoctoni o rifugiati regolari |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To improve knowledge on the prevalence of HCV infection in a hidden population, such as that of illegal, foreign refugees or asylum seekers politicoin an area of southern Italy. These subjects are indeed at high risk of infection by HCV date the origin from high endemic areas for HCV infection. To evaluate the clinical, biochemical and virological subjects anti-HCV positive results. Get a sustained virologic response in all subjects anti-HCV / HCV-RNA positive identified, thanks to a combination regimen of anti-HCV drugs pangenotipica (sofosbuvir / velpatasvir) for 12 weeks |
Migliorare la conoscenza sulla prevalenza dell'infezione da HCV in una popolazione sommersa, quale quella degli stranieri irregolari, rifugiati o richiedenti asilo politicoin un'area del sud italia. Tali soggetti sono infatti ad alto rischio d'infezione da HCV data la proveniebza da zone ad alta endemia per infezione da HCV. Valutare le caratteristiche cliniche, biochimiche e virologiche dei soggetti risultati anti-HCV positivi. Ottenere una risposta virologica sostenuta in tutti i soggetti anti-HCV/HCV-RNA positivi identificati,grazie ad un regime di combinazione di farmaci anti-HCV pangenotipica (sofosbuvir/velpatasvir) per 12 settimane
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Identifying the demographic and behavioral factors associated with positive anti-HCV in the immigrant population studied with the help of cultural mediators who speak not only English, franese, as expected from previous research program, but also Arabic, Somali and other African languages. Tell the studied population health rules to be adopted to reduce the transmission of HCV, after administration of a questionnaire to assess the degree of perception of the problem by spreading an information booklet has been translated into English, French and Arabic. perform a screening of the partners of irregular migrants, asylum seekers and refugees anti_HCV positive about the possibility of a sexual and familial transmission of these infections. Identify factors riischio associated with the non-response to treatment with sofosbuvil + velpatasvir in this population. ; Identifying the demographic and behavioral factors associated with positive anti-HCV in the immigrant population studied with the help of cultural mediators who speak not only English, franese, as expected from previous research program, but also Arabic, Somali and other African languages. Tell the studied population health rules to be adopted to reduce the transmission of HCV, after administration of a questionnaire to assess the degree of perception of the problem by spreading an information booklet has been translated into English, French and Arabic. perform a screening of the partners of irregular migrants, asylum seekers and refugees anti_HCV positive about the possibility of a sexual and familial transmission of these infections. Identify factors riischio associated with the non-response to treatment with sofosbuvil + velpatasvir in this population. |
Identificare i fattori demografici e comportamentali associati alla positività di anti-HCV nella popolazione di immigrati studiati mediante l'ausilio di mediatori culturali che parlano non solo l'inglese, il franese, come previsto dal precedente programma di ricerca, ma anche l'arabo, il somalo e altre lingue africane. Indicare alla popolazione studiata norme sanitarie da adottare per ridurre la trasmissione di HCV, previa somministrazione di un questionario per valutare il grado di percezione del problema, diffondendo un opuscolo informativo tradotto in inglese, francese ed arabo. Screenare i conviventi di immigrati irregolari , richiedenti asilo e rifugiati anti_HCV positivi per l'eventualità di una trasmissione sessuale e familiare di tali infezioni. Identificare fattori di riischio associati alla non-risposta al trattamento con sofosbuvil+velpatasvir in tale popolazione.; Identificare i fattori demografici e comportamentali associati alla positività di anti-HCV nella popolazione di immigrati studiati mediante l'ausilio di mediatori culturali che parlano non solo l'inglese, il franese, come previsto dal precedente programma di ricerca, ma anche l'arabo, il somalo e altre lingue africane. Indicare alla popolazione studiata norme sanitarie da adottare per ridurre la trasmissione di HCV, previa somministrazione di un questionario per valutare il grado di percezione del problema, diffondendo un opuscolo informativo tradotto in inglese, francese ed arabo. Screenare i conviventi di immigrati irregolari , richiedenti asilo e rifugiati anti_HCV positivi per l'eventualità di una trasmissione sessuale e familiare di tali infezioni. Identificare fattori di riischio associati alla non-risposta al trattamento con sofosbuvil+velpatasvir in tale popolazione. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
36 months; 36 months |
36 mesi; 36 mesi |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | Information not present in EudraCT |
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
|
At the SVR evaluation of the last patient enrolled (third month after the end of therapy). |
Alla valutazione di SVR dell'ultimo paziente arruolato(terzo mese dopo la fine della terapia). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |