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

Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

Status: Unknown

Conditions: Hepatitis C, Chronic; Personality Disorders in Prison

Treatments: Other: Peginterferon alfa-2a; Drug: Ribavirin

Study type: Observational

Funder types: Other

Identifiers

NCT01900886

GEI-HCC-2010-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 263 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

263 participants in 1 patient group

Pegasys, injection subcutaneous

Description:

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

Treatment:

Drug: Ribavirin

Other: Peginterferon alfa-2a