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

Hepatitis C, Chronic Clinical Trial

— Perseo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01900886
• Other study ID #: GEI-HCC-2010-01
• Status: Active, not recruiting
• Phase: N/A
• First received: July 8, 2013
• Last updated: July 12, 2013
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2010
• Source: Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 263
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Personality Disorders
• Personality Disorders in Prison

Intervention

Other:
• Peginterferon alfa-2a
Treatment as usual clinical practice

Drug:
• Ribavirin
Treatment as usual clinical practice

Locations

Country	Name	City	State
Spain	Centro Penitenciario de Albolote	Albolote	Granada
Spain	Centro Penitenciario de El Acebuche	Almeria
Spain	Centro Penitenciario de Badajoz	Badajoz
Spain	Centro Penitenciario de Cordoba	Cordoba
Spain	Centro Penitenciario Jaen	Jaen
Spain	Centro Penitenciario El Puerto III	Jerez de la Frontera	Cadiz
Spain	Centro Penitenciario Las Palmas	Las Palmas de Gran Canaria	Islas Canarias
Spain	Centro Penitenciario Ocaña I	Ocaña	Toledo
Spain	Centro Penitenciario de Topas	Salamanca
Spain	Centro Penitenciario de Tenerife	Santa Cruz de Tenerife	Islas Canarias
Spain	Centro Penitenciario Sevilla I	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Viral Response (SVR)		RNA-VHC at weeks 24 or 48	No