treatment of eradication of HCV infection in immigrant patients with innovative drug

innovative model for the eradication of HCV in a population at high risk of irregular immigrants and low-income refugees - Eradication of HCV infection in immigrants subject

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001024-21-IT

Enrollment

6000

Registered

2021-10-01

Start date

2018-02-23

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HCV hepatitis, all fibrosis MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10019755 Term: Hepatitis chronic active System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: EPCLUSA Product Name: EPCLUSA Product Code: 044928012 Pharmaceutical Form: Coated tablet INN or Proposed INN: sofosbuvir/velpatasvir Current Sponsor code: 044928012 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000

Exclusion criteria

Exclusion criteria: Subjects indigenous or registered refugees

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: 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. ;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 identifi	—

Measure

Time frame

Main Objective: 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;Secondary Objective: 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. ;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 identifi

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Secondary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: 36 months; 36 months	—

Measure

Time frame

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.;Timepoint(s) of evaluation of this end point: 36 months; 36 months

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Countries

Italy

Contacts

Public ContactUOC Malattie Infettive

AOU "Luigi Vanvitelli"

nicola.coppola@unicampania.it0815666218

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026