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

• Conditions: Hepatitis C, Chronic; Personality Disorders in Prison
• Interventions: Other: Peginterferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT01900886
• Lead Sponsor: Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

Brief Summary

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.

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 Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Primary Completion: 2013-06
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-12
• Last Update Submitted: 2013-07-12
• Study First Posted: 2013-07-17
• Last Update Posted: 2013-07-17
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 263

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pegasys, injection subcutaneous	Peginterferon alfa-2a	Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)
Pegasys, injection subcutaneous	Ribavirin	Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)

Primary Outcome Measures

Name	Time	Method
Sustained Viral Response (SVR)	RNA-VHC at weeks 24 or 48

Trial Locations

Locations (11)

Centro Penitenciario El Puerto III; 🇪🇸 Jerez de la Frontera, Cadiz, Spain

Centro Penitenciario Ocaña I; 🇪🇸 Ocaña, Toledo, Spain

Centro Penitenciario de Badajoz; 🇪🇸 Badajoz, Spain

Centro Penitenciario de Cordoba; 🇪🇸 Cordoba, Spain

Centro Penitenciario de Albolote; 🇪🇸 Albolote, Granada, Spain

Centro Penitenciario Las Palmas; 🇪🇸 Las Palmas de Gran Canaria, Islas Canarias, Spain

Centro Penitenciario Jaen; 🇪🇸 Jaen, Spain

Centro Penitenciario Sevilla I; 🇪🇸 Sevilla, Spain

Centro Penitenciario de Tenerife; 🇪🇸 Santa Cruz de Tenerife, Islas Canarias, Spain

Centro Penitenciario de El Acebuche; 🇪🇸 Almeria, Spain

Centro Penitenciario de Topas; 🇪🇸 Salamanca, Spain