Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C
This trial is active, not recruiting.
|Conditions||hepatitis c, chronic, personality disorders in prison|
|Treatments||peginterferon alfa-2a, ribavirin|
|Sponsor||Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria|
|Start date||December 2010|
|End date||June 2013|
|Trial size||263 participants|
|Trial identifier||NCT01900886, GEI-HCC-2010-01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Jerez de la Frontera, Spain||Centro Penitenciario El Puerto III||no longer recruiting|
|Albolote, Spain||Centro Penitenciario de Albolote||no longer recruiting|
|Las Palmas de Gran Canaria, Spain||Centro Penitenciario Las Palmas||no longer recruiting|
|Santa Cruz de Tenerife, Spain||Centro Penitenciario de Tenerife||no longer recruiting|
|Ocaña, Spain||Centro Penitenciario Ocaña I||no longer recruiting|
|Almeria, Spain||Centro Penitenciario de El Acebuche||no longer recruiting|
|Badajoz, Spain||Centro Penitenciario de Badajoz||no longer recruiting|
|Cordoba, Spain||Centro Penitenciario de Cordoba||no longer recruiting|
|Jaen, Spain||Centro Penitenciario Jaen||no longer recruiting|
|Salamanca, Spain||Centro Penitenciario de Topas||no longer recruiting|
|Sevilla, Spain||Centro Penitenciario Sevilla I||no longer recruiting|
Sustained Viral Response (SVR)
time frame: RNA-VHC at weeks 24 or 48
Male or female participants from 18 years up to 65 years old.
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.
|Official title||Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "|
|Principal investigator||Andres Marco, Medicine|
|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.|
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