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

Information source: Fundacion IMIM
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Phase: N/A

Status: Active, not recruiting

Sponsored by: Fundacion IMIM

Official(s) and/or principal investigator(s):
Ricard Solà Lamoglia, Dr., Principal Investigator, Affiliation: Hospital del Mar, Barcelona
Ramón Planas Vila, Dr., Principal Investigator, Affiliation: Hospital Germans Tries i Pujol, Barcelona
Javier García-Samaniego, Dr., Principal Investigator, Affiliation: Hospital Carlos III, Madrid
Moisés Diago, Dr., Principal Investigator, Affiliation: Hospital General de Valencia
Manuel Romero, Dr., Principal Investigator, Affiliation: Hospital de Valme, Sevilla
José Luís Calleja, Dr, Principal Investigator, Affiliation: Hospital Puerta del Hierro, Madrid

Summary

The purpose of this study is to describe the management of patients with chronic hepatitis C and previous treatment failure.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Describe the management of patients with chronic hepatitis C and previous treatment failure

Secondary outcome:

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.

To assess the percentage of patients with previous treatment failure who are not candidates for re-treatment and its causes.

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.

To know the causes of the dose modifications and withdrawal of treatment during the follow-up period in patients who start re-treatment.

To know the percentage of patients that achieve sustained viral response when implementing the recommendations based on the cause of the previous therapeutic failure.

To determine the presence of the polymorphism rs12979860 in the gene IL 28B located on chromosome 19.

Compare the management of patients with chronic hepatitis C prior treatment failure before and after the appearance of new treatments.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hospital del Mar, Barcelona, Spain

H. Puerta del Hierro, Madrid, Spain

H. General de Múrcia, Múrcia, Spain

H. Morales Messeguer, Múrcia, Spain

H. Vírgen del Rocío, Sevilla, Spain

H. de Antequera, Antequera, Andalucía, Spain

H. Puerta de Mar, Cádiz, Andalucía, Spain

H. Puerto Real, Cádiz, Andalucía, Spain

H. Vírgen de las Nieves, Granada, Andalucía, Spain

H. Infanta Elena, Huelva, Andalucía, Spain

H. de Jaen, Jaen, Andalucía, Spain

H. de Jerez, Jerez de la Frontera, Andalucía, Spain

H. Carlos Haya, Málaga, Andalucía, Spain

H. Vírgen de la Victoria, Málaga, Andalucía, Spain

H. de Valme, Sevilla, Andalucía, Spain

H. San Jorge, Huesca, Aragón, Spain

H. Clínico de Zaragoza, Zaragoza, Aragón, Spain

H. Miquel Servet, Zaragoza, Aragón, Spain

H. Central de Astúrias, Oviedo, Astúrias, Spain

H. Carlos III, Madrid, C de Madrid, Spain

H. de Alcoy, Alcoy, C. Valenciana, Spain

H. General de Alicante, Alicante, C. Valenciana, Spain

H. Marina Baixa, Alicante, C. Valenciana, Spain

H. de Castellón, Castellón, C. Valenciana, Spain

H. de Elche, Elche, C. Valenciana, Spain

H. Vega Baja, Orihuela, C. Valenciana, Spain

H. Clínico de Valencia, Valencia, C. Valenciana, Spain

H. General de Valencia, Valencia, C. Valenciana, Spain

H. de Xàtiva, Xàtiva, C. Valenciana, Spain

H. de Henares, Alcalá de Henares, C. de Madrid, Spain

Fundación de Alcorcón, Alcorcón, C. de Madrid, Spain

H. de Getafe, Getafe, C. de Madrid, Spain

H. 12 de Octubre, Madrid, C. de Madrid, Spain

H. Fundación Jiménez 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 Astúrias, Madrid, C. de Madrid, Spain

H. Severo Ochoa, Madrid, C. de Madrid, Spain

H. de Móstoles, Móstoles, C. de Madrid, Spain

H. Infanta Cristina, Parla, C. de Madrid, Spain

H. Infanta Sofía, San Sebastian de los Reyes, C. de Madrid, Spain

H. Insular, Gran Canaria, Canarias, Spain

H. Dr. José Molina Orrosos, Lanzarote, Canarias, Spain

H. Candelaria, Tenerife, Canarias, Spain

H. Dr. Negrín, Tenerife, Canarias, Spain

H. Universitario de Tenerife, Tenerife, Canarias, Spain

H. de Valdecilla, Santander, Cantabria, Spain

H. de Albacete, Albacete, Castilla la Mancha, Spain

H. Ciudad Real, Ciudad Real, Castilla la Mancha, Spain

H. de Cuenca, Cuenca, Castilla la Mancha, Spain

H. de Manzanares, Manzanares, Castilla la Mancha, Spain

H. Alcázar, Toledo, Castilla la Mancha, Spain

H. Vírgen de la Salud, Toledo, Castilla la Mancha, Spain

H, de Tomelloso, Tomelloso, Castilla la Mancha, Spain

H. de Valdepeñas, Valdepeñas, Castilla la Mancha, Spain

H. de León, León, Castilla y León, Spain

H. Comarcal el Bierzo, Ponferrada, Castilla y León, Spain

H. Clínico de Salamanca, Salamanca, Castilla y León, Spain

H. Clinico de Valladolid, Valladolid, Castilla y León, Spain

H. Río Ortega, Valladolid, Castilla y León, Spain

H. Germans Trias Pujol, Badalona, Cataluña, Spain

H. Clínic, Barcelona, Cataluña, Spain

H. Sant Boi, Barcelona, Cataluña, Spain

H. Sant Pau, Barcelona, Cataluña, Spain

Hospital de Bellvitge, Barcelona, Cataluña, Spain

Xarxa Sanitaria i Social de Santa Tecla (Tarragona), El Vendrell, Cataluña, Spain

H. de Figueres, Figueres, Cataluña, Spain

H. Josep Trueta, Girona, Cataluña, Spain

H. Santa Caterina, Girona, Cataluña, Spain

H. General de Igualada, Igualada, Cataluña, Spain

H. Sant Joan de Déu de Manresa, Manresa, Cataluña, Spain

H. Sant Joan de Déu de Martorell, Martorell, Cataluña, Spain

H. Sant Joan de Reus, Reus, Cataluña, Spain

H. Parc Taulí de Sabadell, Sabadell, Cataluña, Spain

H. Esperit Sant, Santa Coloma de Gramanet, Cataluña, Spain

H. Joan XXIII, Tarragona, Cataluña, Spain

H. Verge de la Cinta de Tortosa, Tortosa, Cataluña, Spain

H. General de Vic, Vic, Cataluña, Spain

H. de Viladecans, Viladecans, Cataluña, Spain

H. Infanta Cristina, Badajoz, Extremadura, Spain

H. de Coria/Plasencia, Coria, Extremadura, Spain

H. San Pedro Alcántara, Cáceres, Extremadura, Spain

H. de Mérida, Mérida, Extremadura, Spain

Complejo Hospitalario Universitario A Coruña, A Coruña, Galicia, Spain

Complexo Hospitalario Universitario A Coruña, A Coruña, Galicia, Spain

H. Arquitecto Marcide, Ferrol, Galicia, Spain

Complexo Hospitalario Ourense, Ourense, Galicia, Spain

Complexo Hospitalario Pontevedra, Pontevedra, Galicia, Spain

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Galicia, Spain

Complejo hospitalario Vigo, Vigo, Galicia, Spain

H. Meixoeiro, Vigo, Galicia, Spain

H. Xeral Cíes, Vigo, Galicia, Spain

POVISA, Vigo, Galicia, Spain

H. Son Dureta, Mallorca, Illes Balears, Spain

H. Son Llàtzer, Mallorca, Illes Balears, Spain

H. Manacor, Manacor, Illes Balears, Spain

H. Santa Mª del Rosell, Cartagena, Múrcia, Spain

H. de Arritxaca, El Palmar, Múrcia, Spain

H. de Lorca, Lorca, Múrcia, Spain

H. de Navarra, Pamplona, Navarra, Spain

H. Basurto, Bilbao, País Vasco, Spain

H. de Galdakano, Bilbao, País Vasco, Spain

H. las Cruces, Bilbao, País Vasco, Spain

H. de Donosti, San Sebastián, País Vasco, Spain

Additional Information

Starting date: September 2009
Last updated: October 14, 2013

Page last updated: August 20, 2015

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