Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C (Perseo)

July 12, 2013 updated by: Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "

Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Secondary objectives:

  • Describe the management of patients with personality disorders on treatment for hepatitis C in the prison.
  • Describe the characteristics of patients who discontinue the treatment and the reasons for stratifying by the presence of personality disorders.

Study Type

Observational

Enrollment (Anticipated)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almeria, Spain, 04071
        • Centro Penitenciario de El Acebuche
      • Badajoz, Spain, 06071
        • Centro Penitenciario de Badajoz
      • Cordoba, Spain, 14015
        • Centro Penitenciario de Cordoba
      • Jaen, Spain, 23009
        • Centro Penitenciario Jaen
      • Salamanca, Spain, 37799
        • Centro Penitenciario de Topas
      • Sevilla, Spain, 41007
        • Centro Penitenciario Sevilla I
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spain, 11500
        • Centro Penitenciario El Puerto III
    • Granada
      • Albolote, Granada, Spain, 18220
        • Centro Penitenciario de Albolote
    • Islas Canarias
      • Las Palmas de Gran Canaria, Islas Canarias, Spain, 35017
        • Centro Penitenciario Las Palmas
      • Santa Cruz de Tenerife, Islas Canarias, Spain, 38290
        • Centro Penitenciario de Tenerife
    • Toledo
      • Ocaña, Toledo, Spain, 45300
        • Centro Penitenciario Ocaña I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients with chronic hepatitis C mono-or co-infected with HIV.

Description

Inclusion Criteria:

  • Patients 18 years of age.
  • Patients with expected prison stay beyond the duration of follow-up period of the study.
  • Patients with chronic HCV infection and detectable viral load to initiate treatment with standard therapy.
  • Patients their written informed consent to participate in the study.

Exclusion Criteria:

  • Patients previously treated with Interferon (IFN) and Ribavirin (RBV).
  • Patients can not read or understand a written questionnaire at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pegasys, injection subcutaneous
Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)
Other: Peginterferon alfa-2a
Treatment as usual clinical practice
Other Names:
  • Pegasys
Drug: Ribavirin
Treatment as usual clinical practice
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained Viral Response (SVR)
Time Frame: RNA-VHC at weeks 24 or 48
RNA-VHC at weeks 24 or 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

Investigators

  • Principal Investigator: Andres Marco, Medicine, Centro Penitenciario de Hombres de Barcelona. Prisión Modelo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 8, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 12, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEI-HCC-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C, Chronic

Clinical Trials on Peginterferon alfa-2a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe