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

NCT ID: NCT01900886

Last Updated: 2013-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Hepatitis C, Chronic Personality Disorders in Prison

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Pegasys, injection subcutaneous

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

Peginterferon alfa-2a

Intervention Type OTHER

Treatment as usual clinical practice

Ribavirin

Intervention Type DRUG

Treatment as usual clinical practice

Interventions

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Peginterferon alfa-2a

Treatment as usual clinical practice

Intervention Type OTHER

Ribavirin

Treatment as usual clinical practice

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andres Marco, Medicine

Role: PRINCIPAL_INVESTIGATOR

Centro Penitenciario de Hombres de Barcelona. Prisión Modelo

Locations

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Centro Penitenciario de El Acebuche

Almería, Almeria, Spain

Site Status

Centro Penitenciario de Badajoz

Badajoz, Badajoz, Spain

Site Status

Centro Penitenciario El Puerto III

Jerez de la Frontera, Cadiz, Spain

Site Status

Centro Penitenciario Las Palmas

Las Palmas de Gran Canaria, Canary Islands, Spain

Site Status

Centro Penitenciario de Tenerife

Santa Cruz de Tenerife, Canary Islands, Spain

Site Status

Centro Penitenciario de Cordoba

Córdoba, Cordoba, Spain

Site Status

Centro Penitenciario de Albolote

Albolote, Granada, Spain

Site Status

Centro Penitenciario Jaen

Jaén, Jaen, Spain

Site Status

Centro Penitenciario de Topas

Salamanca, Salamanca, Spain

Site Status

Centro Penitenciario Sevilla I

Seville, Sevilla, Spain

Site Status

Centro Penitenciario Ocaña I

Ocaña, Toledo, Spain

Site Status

Countries

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Spain

References

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Marco A, Anton JJ, Trujols J, Saiz de la Hoya P, de Juan J, Faraco I, Cayla JA; Perseo Group. Personality disorders do not affect treatment outcomes for chronic HCV infection in Spanish prisoners: the Perseo study. BMC Infect Dis. 2015 Aug 19;15:355. doi: 10.1186/s12879-015-1102-x.

Reference Type DERIVED
PMID: 26286450 (View on PubMed)

Other Identifiers

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GEI-HCC-2010-01

Identifier Type: -

Identifier Source: org_study_id

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