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

Study Design

Time perspective prospective
Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV)
peginterferon alfa-2a Pegasys
Treatment as usual clinical practice
ribavirin Copegus
Treatment as usual clinical practice

Primary Outcomes

Sustained Viral Response (SVR)
time frame: RNA-VHC at weeks 24 or 48

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria.