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Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)

NCT02768961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-05-18

No results posted yet for this study

Summary

The objectives of this study are:

1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population.
2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population.
3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen.
4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.

Conditions

  • Hepatitis C

Interventions

DRUG

sofosbuvir

Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc. Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines

DRUG

ledipasvir

Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc. Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines

Sponsors & Collaborators

  • Instituto de Investigación Marqués de Valdecilla

    lead OTHER

Principal Investigators

  • Javier Crespo García, MDPhD · Head of Gastroenterology and Hepatology at Hospital Universitario Marqués de Valdecilla

  • Carmen Cobo Pelayo, MD · Ministerio del Interior. Secretaría General de Instituciones Penitenciarias

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-10
Primary Completion
2017-05-10
Completion
2017-05-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02768961 on ClinicalTrials.gov