Epidemiological Study to Evaluate the Management of Patients With Chronic Hepatitis C and Previous Treatment Failure

February 11, 2016 updated by: Ricard Sola, Fundacion IMIM
The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Madrid, Spain
        • H. Puerta del Hierro
      • Múrcia, Spain
        • H. General de Múrcia
      • Múrcia, Spain
        • H. Morales Messeguer
      • Sevilla, Spain
        • H. Virgen del Rocío
    • Andalucía
      • Antequera, Andalucía, Spain
        • H. de Antequera
      • Cádiz, Andalucía, Spain
        • H. Puerta de Mar
      • Cádiz, Andalucía, Spain
        • H. Puerto Real
      • Granada, Andalucía, Spain
        • H. Virgen de las Nieves
      • Huelva, Andalucía, Spain
        • H. Infanta Elena
      • Jaen, Andalucía, Spain
        • H. de Jaen
      • Jerez de la Frontera, Andalucía, Spain
        • H. de Jerez
      • Málaga, Andalucía, Spain
        • H. Carlos Haya
      • Málaga, Andalucía, Spain
        • H. Virgen de la Victoria
      • Sevilla, Andalucía, Spain
        • H. de Valme
    • Aragón
      • Huesca, Aragón, Spain
        • H. San Jorge
      • Zaragoza, Aragón, Spain
        • H. Clínico de Zaragoza
      • Zaragoza, Aragón, Spain
        • H. Miquel Servet
    • Astúrias
      • Oviedo, Astúrias, Spain
        • H. Central de Asturias
    • C de Madrid
      • Madrid, C de Madrid, Spain
        • H. Carlos III
    • C. Valenciana
      • Alcoy, C. Valenciana, Spain
        • H. de Alcoy
      • Alicante, C. Valenciana, Spain
        • H. General de Alicante
      • Alicante, C. Valenciana, Spain
        • H. Marina Baixa
      • Castellón, C. Valenciana, Spain
        • H. de Castellón
      • Elche, C. Valenciana, Spain
        • H. de Elche
      • Orihuela, C. Valenciana, Spain
        • H. Vega Baja
      • Valencia, C. Valenciana, Spain
        • H. Clínico de Valencia
      • Valencia, C. Valenciana, Spain
        • H. General de Valencia
      • Xàtiva, C. Valenciana, Spain
        • H. de Xàtiva
    • C. de Madrid
      • Alcalá de Henares, C. de Madrid, Spain
        • H. de Henares
      • Alcorcón, C. de Madrid, Spain
        • Fundación de Alcorcón
      • Getafe, C. de Madrid, Spain
        • H. de Getafe
      • Madrid, C. de Madrid, Spain
        • H. 12 de Octubre
      • Madrid, C. de Madrid, Spain
        • H. Fundación Jimenez Díaz
      • Madrid, C. de Madrid, Spain
        • H. La Paz
      • Madrid, C. de Madrid, Spain
        • H. La Princesa
      • Madrid, C. de Madrid, Spain
        • H. Príncipe de Asturias
      • Madrid, C. de Madrid, Spain
        • H. Severo Ochoa
      • Móstoles, C. de Madrid, Spain
        • H. de Móstoles
      • Parla, C. de Madrid, Spain
        • H. Infanta Cristina
      • San Sebastian de los Reyes, C. de Madrid, Spain
        • H. Infanta Sofía
    • Canarias
      • Gran Canaria, Canarias, Spain
        • H. Insular
      • Lanzarote, Canarias, Spain
        • H. Dr. José Molina Orrosos
      • Tenerife, Canarias, Spain
        • H. Candelaria
      • Tenerife, Canarias, Spain
        • H. Dr. Negrín
      • Tenerife, Canarias, Spain
        • H. Universitario de Tenerife
    • Cantabria
      • Santander, Cantabria, Spain
        • H. de Valdecilla
    • Castilla la Mancha
      • Albacete, Castilla la Mancha, Spain
        • H. de Albacete
      • Ciudad Real, Castilla la Mancha, Spain
        • H. Ciudad Real
      • Cuenca, Castilla la Mancha, Spain
        • H. de Cuenca
      • Manzanares, Castilla la Mancha, Spain
        • H. de Manzanares
      • Toledo, Castilla la Mancha, Spain
        • H. Alcázar
      • Toledo, Castilla la Mancha, Spain
        • H. Vírgen de la Salud
      • Tomelloso, Castilla la Mancha, Spain
        • H, de Tomelloso
      • Valdepeñas, Castilla la Mancha, Spain
        • H. de Valdepeñas
    • Castilla y León
      • León, Castilla y León, Spain
        • H. De León
      • Ponferrada, Castilla y León, Spain
        • H. Comarcal el Bierzo
      • Salamanca, Castilla y León, Spain
        • H. Clínico de Salamanca
      • Valladolid, Castilla y León, Spain
        • H. Clinico de Valladolid
      • Valladolid, Castilla y León, Spain
        • H. Río Ortega
    • Cataluña
      • Badalona, Cataluña, Spain
        • H. Germans Trias Pujol
      • Barcelona, Cataluña, Spain
        • H. Clinic
      • Barcelona, Cataluña, Spain
        • H. Sant Boi
      • Barcelona, Cataluña, Spain
        • H. Sant Pau
      • Barcelona, Cataluña, Spain
        • Hospital De Bellvitge
      • El Vendrell, Cataluña, Spain
        • Xarxa Sanitaria i Social de Santa Tecla (Tarragona)
      • Figueres, Cataluña, Spain
        • H. de Figueres
      • Girona, Cataluña, Spain
        • H. Josep Trueta
      • Girona, Cataluña, Spain
        • H. Santa Caterina
      • Igualada, Cataluña, Spain
        • H. General de Igualada
      • Manresa, Cataluña, Spain
        • H. Sant Joan de Déu de Manresa
      • Martorell, Cataluña, Spain
        • H. Sant Joan de Déu de Martorell
      • Reus, Cataluña, Spain
        • H. Sant Joan de Reus
      • Sabadell, Cataluña, Spain
        • H. Parc Taulí de Sabadell
      • Santa Coloma de Gramanet, Cataluña, Spain
        • H. Esperit Sant
      • Tarragona, Cataluña, Spain
        • H. Joan XXIII
      • Tortosa, Cataluña, Spain
        • H. Verge de la Cinta de Tortosa
      • Vic, Cataluña, Spain
        • H. General de Vic
      • Viladecans, Cataluña, Spain
        • H. de Viladecans
    • Extremadura
      • Badajoz, Extremadura, Spain
        • H. Infanta Cristina
      • Coria, Extremadura, Spain
        • H. de Coria/Plasencia
      • Cáceres, Extremadura, Spain
        • H. San Pedro Alcántara
      • Mérida, Extremadura, Spain
        • H. de Mérida
    • Galicia
      • A Coruña, Galicia, Spain
        • Complejo Hospitalario Universitario A Coruña
      • A Coruña, Galicia, Spain
        • Complexo Hospitalario Universitario A Coruña
      • Ferrol, Galicia, Spain
        • H. Arquitecto Marcide
      • Ourense, Galicia, Spain
        • Complexo Hospitalario Ourense
      • Pontevedra, Galicia, Spain
        • Complexo Hospitalario Pontevedra
      • Santiago de Compostela, Galicia, Spain
        • Complexo Hospitalario Universitario De Santiago
      • Vigo, Galicia, Spain
        • Complejo hospitalario Vigo
      • Vigo, Galicia, Spain
        • H. Meixoeiro
      • Vigo, Galicia, Spain
        • H. Xeral Cíes
      • Vigo, Galicia, Spain
        • POVISA
    • Illes Balears
      • Mallorca, Illes Balears, Spain
        • H. Son Dureta
      • Mallorca, Illes Balears, Spain
        • H. Son Llatzer
      • Manacor, Illes Balears, Spain
        • H. Manacor
    • Múrcia
      • Cartagena, Múrcia, Spain
        • H. Santa Mª del Rosell
      • El Palmar, Múrcia, Spain
        • H. de Arritxaca
      • Lorca, Múrcia, Spain
        • H. de Lorca
    • Navarra
      • Pamplona, Navarra, Spain
        • H. de Navarra
    • País Vasco
      • Bilbao, País Vasco, Spain
        • H. Basurto
      • Bilbao, País Vasco, Spain
        • H. de Galdakano
      • Bilbao, País Vasco, Spain
        • H. las Cruces
      • San Sebastián, País Vasco, Spain
        • H. de Donosti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients of both sexes older than 18 years old with hepatitis C who had previously failed to the standard therapy.

Description

Inclusion Criteria:

  • Patients of both sexes older than 18 years old.
  • Patients with hepatitis C who had previously failed to the standard therapy.
  • Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

  • Patients with clinical and/or social conditions that might interfere with the development of the study (terminal diseases, cognitive detriment, severe psychiatric disease which prevent from obtaining the information required, prolonged absences during the study).
  • Patients who are participating in other research trials or under treatment with any agent contraindicated according to the summary of product characteristics or other circumstance which requires a patient management different from the investigator's regular clinical practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Describe the management of patients with chronic hepatitis C and previous treatment failure
Time Frame: 6 years
6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To know the frequency of the causes for not responding to the previous treatment: lack of adherence to treatment, incomplete dose of antiviral treatment, insufficient treatment duration or treatment resistance.
Time Frame: 6 years
6 years
To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.
Time Frame: 6 years
6 years
To evaluate the implementation of current recommendations based on the cause of the previous therapeutic failure, in patients with chronic hepatitis C in whom a new course of the antiviral treatment is decided to be administered.
Time Frame: 6 years
6 years
To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment.
Time Frame: 6 years
6 years
To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure.
Time Frame: 6 years
6 years
To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19.
Time Frame: 6
The rs12979860 polymorphism in the gene IL 28B that is located on chromosome 19 showed to be strongly associated with the development of sustained viral response (SVR) in patients with chronic hepatitis C treated with PEG-IFN-α/RBV. Patients with this polymorphism clear the virus more easily.
6
Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments.
Time Frame: 3
3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion IMIM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ricard Solà Lamoglia, Dr., Hospital del Mar
  • Principal Investigator: Ramón Planas Vila, Dr., Hospital Germans Tries i Pujol, Barcelona
  • Principal Investigator: Javier García-Samaniego, Dr., Hospital Carlos III, Madrid
  • Principal Investigator: Moisés Diago, Dr., Hospital General Universitario de Valencia
  • Principal Investigator: Manuel Romero, Dr., Hospital de Valme, Sevilla
  • Principal Investigator: José Luís Calleja, Dr, Hospital Puerta del Hierro, Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGORA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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