MedPath

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

Phase 1
Conditions
Chronic HCV hepatitis, all fibrosis
MedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10019755Term: Hepatitis chronic activeSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2017-001024-21-IT
Lead Sponsor
A.O.U. Università degli Studi della Campania Luigi Vanvitelli
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
6000
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

Subjects indigenous or registered refugees

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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