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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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 Rocio
    • 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 Sofia
    • 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 Llàtzer
      • 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

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

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

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

Fundacion IMIM

Investigators

  • 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

September 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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