Hepatitis C, ChronicPerseoNCT01900886
Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C
An observational study of Hepatitis C, Chronic and Personality Disorders in Prison, run by Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria at 11 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic, Personality Disorders in Prison
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- How many people
- 263 participants
- Where
- 11 sitesSpain
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with chronic hepatitis C mono-or co-infected with HIV.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Centro Penitenciario de Albolote
Albolote, Granada, 18220
Centro Penitenciario de El Acebuche
Almería, Almeria, 04071
Centro Penitenciario de Badajoz
Badajoz, Badajoz, 06071
Centro Penitenciario de Cordoba
Córdoba, Cordoba, 14015
Centro Penitenciario Jaen
Jaén, Jaen, 23009
Centro Penitenciario El Puerto III
Jerez de la Frontera, Cadiz, 11500
Centro Penitenciario Las Palmas
Las Palmas de Gran Canaria, Canary Islands, 35017
Centro Penitenciario Ocaña I
Ocaña, Toledo, 45300
Centro Penitenciario de Topas
Salamanca, Salamanca, 37799
Centro Penitenciario de Tenerife
Santa Cruz de Tenerife, Canary Islands, 38290
Centro Penitenciario Sevilla I
Seville, Sevilla, 41007
About this study
Official title: Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "
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.
Read the detailed 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.
- Being tested
- Peginterferon alfa-2a, Ribavirin
- Keywords
- prison, disorder, hepatitis c
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aOther
Also called Pegasys
Treatment as usual clinical practice
RibavirinDrug
Also called Copegus
Treatment as usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Pegasys, injection subcutaneous | Hepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV) Receives: Other: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR)
Measured: RNA-VHC at weeks 24 or 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startDec 2010
- Primary completionJun 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andres Marco, Medicine, Principal investigator, Centro Penitenciario de Hombres de Barcelona. Prisión Modelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900886
- Sponsor's protocol ID
- GEI-HCC-2010-01
- Acronym
- Perseo
- Status last verified
- Dec 2010
- First submitted
- 8 Jul 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26286450
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Assess Personality Disorders in Prison Populations for Hepatitis C Treatment. "
- ClinicalTrials.gov ID
- NCT01900886
- Acronym / sponsor ID
- Perseo / GEI-HCC-2010-01
- Keywords
- prison, disorder, hepatitis c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad PenitenciariaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegasys, injection subcutaneous | – | Other: Peginterferon alfa-2a, Drug: RibavirinHepatitis C Virus (HCV) patients monoinfected or coinfected, all genotypes, treatment naive to Peginterferon alfa-2a and Ribavirin (RBV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with chronic hepatitis C mono-or co-infected with HIV.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients previously treated with Interferon (IFN) and Ribavirin (RBV).
- Patients can not read or understand a written questionnaire at the discretion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysTreatment as usual clinical practice | Other | Pegasys, injection subcutaneous |
| RibavirinAlso: CopegusTreatment as usual clinical practice | Drug | Pegasys, injection subcutaneous |
Primary outcome
Sustained Viral Response (SVR)
Time frame: RNA-VHC at weeks 24 or 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
- Derived from this study: PubMed 26286450Marco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Marco, Medicine principal investigator
Centro Penitenciario de Hombres de Barcelona. Prisión Modelo
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Personality Disorders in Prison, run by Grupo de Enfermedades Infecciosas de la Sociedad Española de Sanidad Penitenciaria at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Viral Response (SVR) (time frame: RNA-VHC at weeks 24 or 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.